David Miklos
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: Autologous transplantation
- Procedure: Allogeneic transplantation
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Age 18 to 70 years.
- Histologically proven non-Hodgkin's lymphoma
- Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are FDG-PET positive. Eligible patients must have 1) transformed lymphoma, 2) mycosis fungoides that is resistant or refractory to therapy, 3) other histological subtypes in patients that do not have adequate cytoreduction to salvage chemotherapy to reach a minimal disease state, 4) patients in 2nd or greater relapse or 3 or subsequent remission, or 5) other patients with non-Hodgkin's lymphoma felt to have less than a 20% chance of event-free survival with autologous transplant after discussion with the BMT Faculty and the Principal Investigator
* Definition of Minimal Disease State- No individual lymph nodes greater than 2 cm, greater than >75% reduction in a bulky mass (> 10 cm) and < 10% bone marrow involvement with lymphoma.
- ECOG performance status < 2
- Matched related or unrelated donor identified and available. Donor must be a complete match or have only a single allele mismatch.
- Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
- Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control.
- Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration):
* Estimated Creatinine Clearance = (140?age)X WT(kg) X 0.85 if female
72X serum creatinine(mg/dl).
- Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease.
- Patients must have an echocardiogram or MUGA scan within 42 days of registration. If the ejection fraction is < 40%, the patient will not be eligible. If the ejection fraction is 40-50%, patients must have an exercise echocardiogram or dobutamine-echo with a normal response to exercise.
- Patients must have a corrected diffusion capacity > 50% prior to the autologous transplant and > 40% prior to the allogeneic transplant.
- Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible.
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Key Exclusion Criteria:
- Pregnant or breast-feeding women are ineligible due to the known birth defects association with the treatments used in this study.
- Patients known to be human immunodeficiency virus (HIV)-positive are ineligible because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. The antibody test for HIV must be performed within 42 days of registration.
- No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy.
- No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
- Patients with active infection requiring oral or intravenous antibiotics are excluded.
- No prior autologous or allogeneic hematopoietic cell transplantation.
- No prior radioimmunotherapy
- Patient with recurrent/refractory diffuse large B cell lymphoma.
Donor Selection/Evaluation:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 16 ?g/kg of body weight.
- Virology testing including CMV, HIV, EBV, HTLV, RPR, Hepatitis A, B and C will be performed within 30 days of donation.
Additional Study Details
Official Title:
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's LymphomaAnticipated start date:
1/19/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Event-free survival
- Toxicity
Secondary Outcomes:
- Kinetics of donor hematopoietic cell engraftment and chimerism.
- Incidence and extent of acute and chronic GVHD
- Overall and non-relapse mortality rate
- Incidence of chemotherapy-associated pneumonitis
Total Number to be Enrolled:
25Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- 97623
- BMT185
- NCT00481832
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/19/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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