Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer
|ClinicalTrials.gov Identifier: NCT00296023|
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : October 4, 2012
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation||Not Applicable|
- Determine the safety of non-myeloablative allogeneic peripheral blood stem cell transplantation, in terms of regimen-related organ toxicity and toxicity from acute graft-vs-host disease (GVHD), in older or medically frail patients with high-risk indolent hematologic malignancies.
- Determine overall survival, disease-free survival, and relapse risk at 1, 2, and 3 years post-transplantation in these patients.
- Determine the engraftment of donor hematopoiesis at 6 weeks, 3 and 6 months, and 1 year post-transplantation in these patients.
- Determine the incidence and severity of chronic GVHD in older and medically infirm patients treated with this regimen.
- Determine the safety and efficacy of collecting peripheral blood stem cells from older donors (age > 60 years).
- Determine the need and efficacy of donor lymphocyte infusions in patients with residual disease after transplant.
- Non-myeloablative preparative regimen:Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours every 8 hours on days -4 and -3, and anti-thymocyte globulin IV over 8 hours on days -4 to -1.
- Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts recover.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally every 12 hours or IV continuously beginning on day -2 and continuing until day 90, followed by a taper until day 180. Patients also receive methotrexate IV over 15-30 minutes on days 1, 3, 6, and 11.
- Donor lymphocyte infusions (DLIs): Patients with residual disease ≥ 6 months post-transplantation who are off immunosuppression for ≥ 30 days with no evidence of GVHD may receive DLIs. DLIs are administered ≥ 12 weeks apart in the presence of persistent disease, absence of severe (grade 3-4) GVHD, and absence of persistent GVHD after the first DLI.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2008|
|Experimental: stem cell transplant||Biological: anti-thymocyte globulin Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: busulfan Drug: fludarabine phosphate Drug: methotrexate Drug: tacrolimus Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation|
- Toxicity and survival [ Time Frame: up to 36 months post transplant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296023
|United States, California|
|Alta Bates Comprehensive Cancer Center|
|Berkeley, California, United States, 94704|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-0324|
|Principal Investigator:||Thomas G. Martin, MD||University of California, San Francisco|
|Principal Investigator:||Willis Navarro, MD||University of California, San Francisco|
|Principal Investigator:||Charles A. Linker, MD||University of California, San Francisco|