Clinical Trials Unit
Stanford University School of Medicine's Center for Advanced Dermatologic Investigation is the Dermatology Department's clinical trials unit.
The Center is home to 12-15 ongoing clinical studies, investigating the safety and efficacy of new and currently available drugs and over-the-counter medications. The Center works with Stanford's own panel on medical research, leading pharmaceutical companies,and the Food and Drug Administration to safely and ethically expand the medical field's knowledge of dermatologic treatments. New studies begin regularly, and the Center continues to recruit patients with skin aging, sun damage, skin cancer (including basal cell carcinomas), psoriasis, atopic dermatitis, rosacea, and other dermatologic diseases for ongoing studies.
Skin Aging Studies
We seek to understand the human aging processes as it relates to skin on a fundamental level. To this end, our studies focus on clinical and translational research efforts ranging from: (1) the analysis of gene changes which predispose individuals to exceptionally youthful skin to (2) molecular signatures that may be biomarkers for aging skin to (3) the careful study of new candidate agents which might affect the skin aging process.
Nonmelanoma Skin Cancer
Recent advances in our understanding of basal cell skin cancer biology have enabled the development of cutting edge study drugs which combat tumor growth. We are currently home to a number of clinical trials at the forefront of potential therapy for advanced or metastatic basal cell cancer. In addition, we seek to understand the biology of basal cell skin cancers and to identify molecular predictors for treatment success.
Acne Rosecea
This is a common and frustrating chronic inflammatory condition of the face, usually affecting older individuals. The causes of this complex condition are the subject of much study. Our clinical studies seek to identify new topical or oral medications to improve the symptoms of acne rosacea.
Contact
For more information, please email dermtrials@stanford.edu
Featured Clinical Trials
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Dexrazoxane Hydrochloride
- drug: Doxorubicin
- drug: Etoposide
- biological: Filgrastim
- drug: Ifosfamide
- drug: Imatinib Mesylate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Methylprednisolone
- drug: Pegaspargase
- drug: Prednisolone
- other: Questionnaire Administration
- drug: Therapeutic Hydrocortisone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Calaspargase Pegol
Eligibility
Inclusion Criteria:
- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required
diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on
AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if
marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or
ABL-class fusion must be submitted for rapid central review within 72 hours of
study enrollment
- >= 1 year (365 days) and =< 21 years at ALL diagnosis
- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]
definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in
situ hybridization (FISH) and/or molecular methodologies
- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.
ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,
CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization
(FISH, e.g. using break-apart or colocalization signals probes), multiplex or
singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole
transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA
Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
- Ph+ patients must have previously started Induction therapy, which includes
vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or
other standard cytotoxic chemotherapy
- Ph+ patients have not received more than 14 days of multiagent Induction therapy
beginning with the first dose of vinCRIStine
- Ph+ patients may have started imatinib prior to study entry but have not received more
than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of
multiagent Induction chemotherapy (Induction IA phase)
- ABL-class fusion patients may have started imatinib during Induction IA, at the same
time of or after the first vinCRIStine dose
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were
performed at or after initial ALL diagnosis, before study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as
follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of treatment according to
protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any TKI other than imatinib
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618
I'm interested
Psoriasis Clinical Trials
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Dexrazoxane Hydrochloride
- drug: Doxorubicin
- drug: Etoposide
- biological: Filgrastim
- drug: Ifosfamide
- drug: Imatinib Mesylate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Methylprednisolone
- drug: Pegaspargase
- drug: Prednisolone
- other: Questionnaire Administration
- drug: Therapeutic Hydrocortisone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Calaspargase Pegol
Eligibility
Inclusion Criteria:
- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required
diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on
AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if
marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or
ABL-class fusion must be submitted for rapid central review within 72 hours of
study enrollment
- >= 1 year (365 days) and =< 21 years at ALL diagnosis
- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]
definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in
situ hybridization (FISH) and/or molecular methodologies
- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.
ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,
CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization
(FISH, e.g. using break-apart or colocalization signals probes), multiplex or
singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole
transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA
Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
- Ph+ patients must have previously started Induction therapy, which includes
vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or
other standard cytotoxic chemotherapy
- Ph+ patients have not received more than 14 days of multiagent Induction therapy
beginning with the first dose of vinCRIStine
- Ph+ patients may have started imatinib prior to study entry but have not received more
than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of
multiagent Induction chemotherapy (Induction IA phase)
- ABL-class fusion patients may have started imatinib during Induction IA, at the same
time of or after the first vinCRIStine dose
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were
performed at or after initial ALL diagnosis, before study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as
follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of treatment according to
protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any TKI other than imatinib
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618
I'm interested
Dermatology Clinical Trials
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Dexrazoxane Hydrochloride
- drug: Doxorubicin
- drug: Etoposide
- biological: Filgrastim
- drug: Ifosfamide
- drug: Imatinib Mesylate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Methylprednisolone
- drug: Pegaspargase
- drug: Prednisolone
- other: Questionnaire Administration
- drug: Therapeutic Hydrocortisone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Calaspargase Pegol
Eligibility
Inclusion Criteria:
- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required
diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on
AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if
marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or
ABL-class fusion must be submitted for rapid central review within 72 hours of
study enrollment
- >= 1 year (365 days) and =< 21 years at ALL diagnosis
- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]
definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in
situ hybridization (FISH) and/or molecular methodologies
- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.
ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,
CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization
(FISH, e.g. using break-apart or colocalization signals probes), multiplex or
singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole
transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA
Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
- Ph+ patients must have previously started Induction therapy, which includes
vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or
other standard cytotoxic chemotherapy
- Ph+ patients have not received more than 14 days of multiagent Induction therapy
beginning with the first dose of vinCRIStine
- Ph+ patients may have started imatinib prior to study entry but have not received more
than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of
multiagent Induction chemotherapy (Induction IA phase)
- ABL-class fusion patients may have started imatinib during Induction IA, at the same
time of or after the first vinCRIStine dose
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were
performed at or after initial ALL diagnosis, before study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as
follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of treatment according to
protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any TKI other than imatinib
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618
I'm interested
Pediatric Dermatology Clinical Trials
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Dexrazoxane Hydrochloride
- drug: Doxorubicin
- drug: Etoposide
- biological: Filgrastim
- drug: Ifosfamide
- drug: Imatinib Mesylate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Methylprednisolone
- drug: Pegaspargase
- drug: Prednisolone
- other: Questionnaire Administration
- drug: Therapeutic Hydrocortisone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Calaspargase Pegol
Eligibility
Inclusion Criteria:
- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required
diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on
AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if
marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or
ABL-class fusion must be submitted for rapid central review within 72 hours of
study enrollment
- >= 1 year (365 days) and =< 21 years at ALL diagnosis
- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]
definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in
situ hybridization (FISH) and/or molecular methodologies
- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.
ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,
CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization
(FISH, e.g. using break-apart or colocalization signals probes), multiplex or
singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole
transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA
Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
- Ph+ patients must have previously started Induction therapy, which includes
vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or
other standard cytotoxic chemotherapy
- Ph+ patients have not received more than 14 days of multiagent Induction therapy
beginning with the first dose of vinCRIStine
- Ph+ patients may have started imatinib prior to study entry but have not received more
than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of
multiagent Induction chemotherapy (Induction IA phase)
- ABL-class fusion patients may have started imatinib during Induction IA, at the same
time of or after the first vinCRIStine dose
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were
performed at or after initial ALL diagnosis, before study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as
follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of treatment according to
protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any TKI other than imatinib
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618
I'm interested
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Dexrazoxane Hydrochloride
- drug: Doxorubicin
- drug: Etoposide
- biological: Filgrastim
- drug: Ifosfamide
- drug: Imatinib Mesylate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Methylprednisolone
- drug: Pegaspargase
- drug: Prednisolone
- other: Questionnaire Administration
- drug: Therapeutic Hydrocortisone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Calaspargase Pegol
Eligibility
Inclusion Criteria:
- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required
diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on
AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if
marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or
ABL-class fusion must be submitted for rapid central review within 72 hours of
study enrollment
- >= 1 year (365 days) and =< 21 years at ALL diagnosis
- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]
definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in
situ hybridization (FISH) and/or molecular methodologies
- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.
ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,
CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization
(FISH, e.g. using break-apart or colocalization signals probes), multiplex or
singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole
transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA
Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
- Ph+ patients must have previously started Induction therapy, which includes
vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or
other standard cytotoxic chemotherapy
- Ph+ patients have not received more than 14 days of multiagent Induction therapy
beginning with the first dose of vinCRIStine
- Ph+ patients may have started imatinib prior to study entry but have not received more
than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of
multiagent Induction chemotherapy (Induction IA phase)
- ABL-class fusion patients may have started imatinib during Induction IA, at the same
time of or after the first vinCRIStine dose
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were
performed at or after initial ALL diagnosis, before study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as
follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of treatment according to
protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any TKI other than imatinib
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618
I'm interested
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Dexrazoxane Hydrochloride
- drug: Doxorubicin
- drug: Etoposide
- biological: Filgrastim
- drug: Ifosfamide
- drug: Imatinib Mesylate
- other: Laboratory Biomarker Analysis
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Methylprednisolone
- drug: Pegaspargase
- drug: Prednisolone
- other: Questionnaire Administration
- drug: Therapeutic Hydrocortisone
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Calaspargase Pegol
Eligibility
Inclusion Criteria:
- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required
diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on
AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if
marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or
ABL-class fusion must be submitted for rapid central review within 72 hours of
study enrollment
- >= 1 year (365 days) and =< 21 years at ALL diagnosis
- Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed
phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]
definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in
situ hybridization (FISH) and/or molecular methodologies
- ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.
ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,
CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization
(FISH, e.g. using break-apart or colocalization signals probes), multiplex or
singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole
transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA
Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
- Ph+ patients must have previously started Induction therapy, which includes
vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or
other standard cytotoxic chemotherapy
- Ph+ patients have not received more than 14 days of multiagent Induction therapy
beginning with the first dose of vinCRIStine
- Ph+ patients may have started imatinib prior to study entry but have not received more
than 14 days of imatinib
- ABL-class fusion patients must have previously completed the 4 or 5 weeks of
multiagent Induction chemotherapy (Induction IA phase)
- ABL-class fusion patients may have started imatinib during Induction IA, at the same
time of or after the first vinCRIStine dose
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were
performed at or after initial ALL diagnosis, before study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as
follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant since fetal toxicities and teratogenic effects
have been noted for several of the study drugs; a pregnancy test is required for
female patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of treatment according to
protocol
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any TKI other than imatinib
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jenny Joaquin
650-723-0618
I'm interested