Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Reduced Intensity Allogeneic Hematopoietic Cell Transplantation for Patients With Hematological Diseases|
- Treatment-related Mortality Within the First 6 Months After Transplantation [ Time Frame: 6 months ]
- Complete Response [ Time Frame: monthly ]
- Overall Survival [ Time Frame: monthly ]
- Disease-free Survival [ Time Frame: monthly ]
- Graft-versus-host Disease [ Time Frame: monthly ]
- Iron Status at the Time of Transplantation [ Time Frame: baseline ]
- Quality of Life at the Time of Transplantation [ Time Frame: baseline ]
- Treatment-related Mortality at 100 Days After Transplantation [ Time Frame: 100 days ]
|Study Start Date:||February 2007|
|Study Completion Date:||August 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
- Determine the feasibility (i.e., risk of treatment-related mortality during the first 6 months after transplantation) of administering reduced-intensity allogeneic hematopoietic stem cell transplantation to patients with hematologic cancer or other diseases.
- Determine the response rate (partial and complete response), 6- and 12-month probabilities of response, and time to progression in patients treated with this regimen.
- Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine other toxicities of this regimen in these patients.
- Determine the overall survival and disease-free survival of patients treated with this regimen.
- Determine the impact of iron status on overall and disease-free survival.
- Determine the influence of quality of life (at time of transplantation) on overall survival.
- Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3. Patients also receive busulfan IV over 2 hours every 6 hours on days -4 and -3 or melphalan IV over 2 hours on day -3.
- Graft-versus-host disease (GVHD) prophylaxis: Patients with matched related donors receive oral tacrolimus twice daily on days -1 to 90 followed by a taper until day 180. Patients also receive methotrexate IV on days 1, 3, and 6. Patients with matched unrelated and 9/10 matched related donors receive oral tacrolimus twice daily on days -1 to 180 followed by a taper; methotrexate IV on days 1, 3, 6, and 11; and oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper. All patients also receive antithymocyte globulin IV over 4 to 6 hours once a day on days -4 to -1.
- Allogeneic stem cell transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. Patients receive filgrastim (G-CSF) beginning on day 7 and continuing until blood counts recover.
- Lymphocyte infusion: Patients with progressive or stable disease while off immunosuppression and no active GVHD may receive up to 3 donor lymphocyte infusions from the original donor at 8-week intervals beginning on day 180 or 210 .
Quality of life is assessed at baseline.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453206
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||David Hurd, MD||Wake Forest University Health Sciences|