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Not Recruiting
Trial ID: NCT00481832
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)
Inclusion Criteria:
- Age 18 to 70 years.
- Histologically proven non-Hodgkin's lymphoma
- Relapse after achieving initial remission or failure to achieve initial remission.
- KPS > 70%
- Matched related or unrelated donor identified and available. Donor must be a complete
match or have only a single allele mismatch.
- Recent Bone marrow biopsy and cytogenetic analysis
- 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
> 50 cc/min by the following formula (all tests must be performed within 28 days prior
to mobilization ): Estimated Creatinine Clearance = (140 age) X WT(kg) X 0.85 if
female 72 X 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.
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.
- Patients with prior maligancies diagnosed > 5 years ago without evidence of disease
are eligible. Patients with a prior malignancy treated < 5 years ago but have a life
expectancy of > 5 years for that malignancy are eligible.
- Patients with uncontrolled infection.
- No prior autologous or allogeneic hematopoietic cell transplantation.
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 µg/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.
- 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 donor has been
disease-free for five years
drug: Cyclophosphamide
drug: Etoposide
drug: Filgrastim
drug: Mycophenolate mofetil
drug: Antithymocyte globulin
drug: Cyclosporine
drug: rituximab
drug: BCNU
procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT)
procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
procedure: Total lymphoid irradiation
drug: CD34+ Cells
drug: Solu-Medrol
Not Recruiting
Stanford University
School of Medicine
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Stanford,
CA
94305
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