Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte globulin may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer.
Multiple Myeloma and Plasma Cell Neoplasm
Biological: anti-thymocyte globulin
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies|
- Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 1998|
|Study Completion Date:||August 2011|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Fludarabine (30mg/m2/day x 5 days on days -9 to -5), cyclophosphamide (2gm/m2/day on day -5), antithymocyte globulin (10mg/kg/day x 4 days on days -5 to -2), tacrolimus (.03 mg/kg/day IVPB continuous infusion), mycophenolate mofetil (1mg PO BID, days +1 to +60), allogenic peripheral blood stem cells
|Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation|
OBJECTIVES: I. Determine the effect of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation on hematopoietic recovery in patients with hematologic malignancies. II. Determine the toxicities of this regimen in these patients. III. Determine the frequency of mixed hematopoietic chimerism in these patients after this therapy. IV. Determine the efficacy and toxicity of donor leukocyte infusions at relapse in these patients. V. Determine the response rates and survival of these patients after this therapy. VI. Determine the immune reconstitution of patients undergoing this therapy.
OUTLINE: Patients receive fludarabine IV over 30 minutes on days -9 to -5, cyclophosphamide IV over 1 hour on day -5, and antithymocyte globulin IV over 10 hours on days -5 to -2. Allogeneic peripheral blood stem cells are infused on day 0. Patients who achieve complete remission (CR) and then relapse or patients who achieve less than a CR before day 60 receive donor leukocyte infusions (DLI) over 30 minutes. DLI are repeated as necessary for persistent disease. Patients are followed at 1, 3, and 6 months, then at 1 and 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004145
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Study Chair:||Todd M. Zimmerman, MD||University of Chicago|