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Phase II Daratumumab Pomalidomide & Dexamethasone in Relapsed/Refractory Light Chain Amyloidosis
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This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Michaela Liedtke, MD, .
Stanford Investigators
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Phase III CAEL-101 &PCD Tx vs Placebo &PCD Tx in PCD Tx-Naive w/ Mayo Stage IIIb AL Amyloidosis
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AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.
The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I/II AG-221 in Advanced Hematologic Malignancies with an IDH2 Mutation
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The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are:
* To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies.
* To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies.
The primary objective of Phase 2 is:
• To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.
Stanford is currently not accepting patients for this trial.
For more information, please contact Leilani Hong Lien, 650-725-0437.
Stanford Investigators
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Phase I/II Inotuzumab Ozogamicin In Relapsed or Refractory CD22-Positive ALL
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The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.
Stanford is currently not accepting patients for this trial.
For more information, please contact Vani Jain, 6507255459.
Stanford Investigators
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Phase II Dasatinib Followed by Transplantation in Newly Diagnosed Ph+ ALL
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This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joselene Sipin-Sayno, 6507368113.
Stanford Investigators
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Phase II Magrolimab Combinations in Relapsed/Refractory Multiple Myeloma
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The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab, in combination with other anticancer therapies in participants with relapsed/refractory multiple myeloma.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Extension NEOD001 in Light Chain (AL) Amyloidosis
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The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability. All subjects in the current NEOD001 trials are being dosed at 24 mg/kg, which will be continued in this study.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage ALL
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This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joselene Sipin-Sayno, 650-736-8113.
Stanford Investigators
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Phase I ALLO-715 &ALLO-647 Eval Anti-BCMA Allogeneic CAR T Cell Treatment +/- Nirogacestat in R/R MM
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The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.
Stanford is currently not accepting patients for this trial.
For more information, please contact Michaela Liedtke, MD, 650-498-6000.
Stanford Investigators
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Phase I bb2121 in BCMA-Expressing Multiple Myeloma
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Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM).
Stanford is currently not accepting patients for this trial.
For more information, please contact Reneth Tien, 650-723-0646.
Stanford Investigators
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Phase III Consolidation with VRD vs VD in MM after Dexamethasone Based Induction Tx
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This randomized phase III trial compares bortezomib, dexamethasone, and lenalidomide with bortezomib and dexamethasone to see how well they work in treating patients with multiple myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib and dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
Stanford is currently not accepting patients for this trial.
For more information, please contact Nancy Mori, 6507240201.
Stanford Investigators
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Phase IB BET Inhibitor RO6870810 - Given as Mono & Combination Therapy in Advanced Multiple Myeloma
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This is a Phase Ib, open-label, multicenter, global study designed to assess the safety and tolerability of RO6870810 as monotherapy and in combination with daratumumab in participants with relapsed/refractory multiple myeloma. Each treatment cycle will be 21 days in length. There are two parts to this study. A dose-escalation phase (Part I) will be used to evaluate the safety and tolerability and dose limiting toxicities, and to establish the maximum tolerated dose (MTR)/optimum biological dose (OBD) of RO6870810 when given as monotherapy or in combination with daratumumab. A dose-expansion phase (Part II) will further characterize the safety, tolerability and activity of RO6870810 as monotherapy or in combination with daratumumab at the defined expansion dose-levels.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Intergroup Clinical Trial For Adolescents & Young Adults With Untreated ALL
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joselene Sipin-Sayno, 6507368113.
Stanford Investigators
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Phase III Inotuzumab Ozogamicin vs Defined Investigator's Choice in Relapsed/Refractory CD22+ ALL
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This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Phase I/II CEP-18770 in Relapsed Multiple Myeloma Refractory to the Most Recent Therapy
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The primary objective for part 1 of the study is to determine the maximum tolerated dose (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated at the MTD.
Stanford is currently not accepting patients for this trial.
For more information, please contact Leonel Gallegos, 6507232781.
Stanford Investigators
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Phase I Amrubicin plus Lenalidomide and Weekly Dexamethasone in Relapsed/Refractory MM
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To assess if amrubicin is safe and useful for patients with multiple myeloma requiring additional treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Kashif Naseem, 650-724-3155.
Stanford Investigators
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Phase III NEOD001 + SoC vs Placebo + SoC in Light Chain (AL) Amyloidosis
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This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Phase I 1st-in-Human BCL-2Inhibitor ABBV-453 in Biomarker-SelectedRelapsed/RefractoryMultipleMyeloma
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Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed.
ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2, participants are placed in 1 of 3 groups called treatment arms. Each group receives a different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites worldwide.
In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and oral dexamethasone tablets once weekly, in 28-day cycles.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mani Gupta, 650-723-0501.
Stanford Investigators
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COVALENT-101: A Phase I FIH BMF-219 Oral Covalent Menin Inhibitor, in AL, DLBCL, MM, CLL, and SLL
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A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mani Gupta, 650-723-0501.
Stanford Investigators
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Phase Ib/II Entospletinib +Vincristine &Dexamethasone in Relapsed /Refractory ALL
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The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL).
This is a dose escalation study in which after 2 induction cycles participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I First-in-Human Study of Single-Agent ISB 2001 in Relapsed/Refractory Multiple Myeloma
Recruiting
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This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).
Stanford Investigators
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Phase II Hyper-CVAD + Dasatinib +/- Allogeneic Stem Cell Transplant in Ph Chromosome + and/or ALL
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This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
Stanford is currently not accepting patients for this trial.
For more information, please contact Vani Jain, 6507255459.
Stanford Investigators
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Phase III CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Vs Cytarabine & Daunorubicin in AML
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To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marlene Zuraek, 6507364031.
Stanford Investigators
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Phase III bb2121 vs Standard Regimens in Relapsed & Refractory Multiple Myeloma (RRMM) (KarMMa-3)
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This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).
The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase 1/1b Bcl-2 Inhibitor BGB-11417 in Mature B-Cell Malignancies
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The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III RVD versus RVD plus auto SCT in newly diagnosed Multiple Myeloma
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In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Expanded Tx Panobinostat(LBH589)+Bortezomib+Dexamethasone in Relapsed & Refractory Multiple Myeloma
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This will be a multi-center, open label, expanded treatment protocol of panobinostat, bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Panobinostat will be administered at a starting dose of 20mg orally three times a week (every other day) for two weeks on and one week off, with dose adjustments permitted based on observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously, twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients who have achieved stable disease or better by modified EBMT 1998 criteria may continue combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable disease or better may continue on therapy at the discretion of their investigator until September 2015 or until drug is commercially available, whichever comes first. Patients who have not achieved at least stable disease by 8 cycles must discontinue from study treatment. Dexamethasone will be administered on the day of and the day immediately following bortezomib treatment. Patients will not receive any study treatment during the third week of each cycle. Cycles will be defined as 21 days of treatment. Investigators may not add any other anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study treatment. Patients will remain on study until disease progression, unacceptable toxicity, or end of the study
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Phase II CAEL-101 in AL Amyloidosis
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AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.
The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab .
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma
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This phase III trial compares the effect of adding levocarnitine to standard chemotherapy versus (vs.) standard chemotherapy alone in protecting the liver in patients with leukemia or lymphoma. Asparaginase is part of the standard of care chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), and mixed phenotype acute leukemia (MPAL). However, in adolescent and young adults (AYA) ages 15-39 years, liver toxicity from asparaginase is common and often prevents delivery of planned chemotherapy, thereby potentially compromising outcomes. Some groups of people may also be at higher risk for liver damage due to the presence of fat in the liver even before starting chemotherapy. Patients who are of Japanese descent, Native Hawaiian, Hispanic or Latinx may be at greater risk for liver damage from chemotherapy for this reason. Carnitine is a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is necessary for metabolism and its deficiency or absence is associated with liver and other organ damage. Levocarnitine is a drug used to provide extra carnitine. Laboratory and real-world usage of the dietary supplement levocarnitine suggests its potential to prevent or reduce liver toxicity from asparaginase. The overall goal of this study is to determine whether adding levocarnitine to standard of care chemotherapy will reduce the chance of developing severe liver damage from asparaginase chemotherapy in ALL, LL and/or MPAL patients.
Stanford Investigators
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Phase I/II MLN9708 +/- Lenalidomide & Dexamethasone in Multiple Myeloma Requiring Systemic Treatment
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The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
Stanford is currently not accepting patients for this trial.
For more information, please contact Vani Jain, 6507255459.
Stanford Investigators
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Phase 1/2 NEOD001 in Light Chain (AL) Amyloidosis
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Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Phase I SEA-BCMA in Relapsed or Refractory Multiple Myeloma
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This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.
The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.
In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I Inotuzumab Ozogamicin with CVP in Relapsed/Refractory CD22+ Acute Leukemia
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This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.
Stanford is currently not accepting patients for this trial.
For more information, please contact Kevin Morrison, 650-725-5450.
Stanford Investigators
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Phase III CAEL-101 &PCD Tx vs Placebo &PCD Tx in PCD Tx-Naive w/ Mayo Stage IIIa AL Amyloidosis
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AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.
The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIa AL amyloidosis.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Subcutaneous Bortezomib plus Chemo (VXLD) in Relapsed/Refractory ALL
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This study evaluates the value of bortezomib in combination with specified chemotherapies for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact Uzma Ahmed, 650-723-0670.
Lead Sponsor
Stanford Investigators
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Longterm Follow-up of Subjects Treated with bb2121
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This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.
bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No investigational treatment will be administered in this study.
After completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase III Inotuzumab Ozogamicin(Anti-CD22 Mab) vs Frontline Tx in NewlyDiagnosedPrecursor B-Cell ALL
Recruiting
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This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
Stanford Investigators
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Connect MM: The Multiple Myeloma Disease Registry
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The purpose of the Connect® MM Registry is to explore the natural history and real world management of patients with newly diagnosed symptomatic multiple myeloma (MM) and provide unique insights into the management of MM and the impact of this hematologic disorder on patients.
Stanford Investigators
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Ph 2b NEOD001 in Previously Treated Light Chain (AL) Amyloidosis
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This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and have persistent cardiac dysfunction.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Phase I Carfilzomib in Previously-Treated Systemic Light-Chain (AL) Amyloidosis
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This is a dose finding study to evaluate the safety and determine the maximum tolerated dose of carfilzomib in patients with previously treated systemic light-chain amyloidosis.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Stanford Investigators
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Phase III Cyclophosphamide Bortezomib Dexamethasone +/- Daratumumab in Systemic AL Amyloidosis
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The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I Bortezomib (VELCADE) in Combo with Pralatrexate in Relapsed/Refractory MM
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The purpose of this trial is to find out the maximum tolerated dose (MTD) of bortezomib (VELCADE) in combination with pralatrexate in patients with previously treated multiple myeloma, AL amyloid and Waldenstroem's macroglobulinemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact Ying Hao, 650-723-0646.
Lead Sponsor
Stanford Investigators
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Phase II Idarubicin & Ara-C +/- Pravastatin in Poor-Risk Acute Myelogenous Leukemia(AML)
Not Recruiting
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RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia (AML).
ADDITIONAL BACKGROUND: S0919 was initially designed for patients with relapsed acute myeloid leukemia (AML), where the patient's preceding remission had lasted ≥ 3 months. The null response rate was 30%. The study closed to accrual on Nov 1, 2012 after meeting the defined criterion for a positive study; and the results are being submitted to the American Society of Clinical Oncology meeting. Based on the promising results from this trial, the trial has now been amended to evaluate this therapeutic regimen in poor-risk patients (patients with newly diagnosed acute myeloid leukemia (AML) arising out of myelodysplastic syndrome (MDS), primary refractory acute myeloid leukemia (AML), and relapsed acute myeloid leukemia (AML) with the patient's preceding remission lasting \< 6 months).
Stanford is currently not accepting patients for this trial.
For more information, please contact Joselene Sipin-Sayno, 650-736-8113.
Stanford Investigators
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Phase II Inotuzumab +Chemo vs Standard Chemo in Philadelphia-Chromosome-Negative B-Cell ALL
Not Recruiting
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This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.
Stanford is currently not accepting patients for this trial.
For more information, please contact Caitlyn Minas, 650-723-0646.
Stanford Investigators
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Phase I CC-98633 BCMA Targeted NEX-T CAR T Cells, in Relapsed and/or Refractory Multiple Myeloma
Not Recruiting
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This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants with relapsed and/or refractory multiple myeloma.
The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose RP2D(s); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D(s).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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