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Radiation Therapy and Fludarabine Followed by Donor Peripheral Stem Cell Transplantation, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Hematologic Cancer

2014-08-27 03:57:00 | BioPortfolio

Summary

RATIONALE: Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells from a donor can be rejected by the body's normal cells. Mycophenolate mofetil and cyclosporine may prevent this from happening.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and fludarabine followed by donor peripheral stem cell transplantation, mycophenolate mofetil, and cyclosporine in treating patients who have hematologic cancer.

Description

OBJECTIVES:

- Determine the rate of grade III/IV graft-versus-host disease (GVHD) in patients with hematologic malignancies treated with low-dose radiotherapy and fludarabine followed by allogeneic peripheral blood stem cell transplantation, mycophenolate mofetil, and cyclosporine.

- Determine the risk of graft rejection and GVHD in patients treated with this regimen.

- Determine the non-relapse mortality and disease response in patients treated with this regimen.

- Determine the incidence and severity of infectious complications in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment regimens according to disease risk (indolent vs aggressive).

Patients may receive cytoreductive chemotherapy and/or radiotherapy to high-risk sites of bulky disease. All patients then receive conditioning therapy comprising fludarabine IV on days -4 to -2. Patients undergo low-dose total body irradiation followed by unmodified allogeneic peripheral blood stem cell or bone marrow transplantation on day 0. Patients receive oral mycophenolate mofetil (MMF) daily on days 0-27.

Regimen A

- Indolent disease including:

- Chronic lymphocytic leukemia, chronic myelogenous leukemia (CML) in first chronic phase

- Acute myeloid leukemia (AML) in first complete remission (CR)

- Refractory anemia with ringed sideroblasts (RARS)

- Myeloma in CR or partial remission (PR)

- Low-grade non-Hodgkin's lymphoma (NHL)

- Aggressive NHL in first CR Patients receive oral cyclosporine twice daily beginning on day -3. If there is no evidence of graft-versus-host disease (GVHD), cyclosporine is tapered from day 56 until discontinuation by day 180. Beginning at least 2 weeks after completion of cyclosporine, patients with progressive disease receive donor lymphocyte infusion (DLI) IV over 30 minutes for up to 3 infusions. Patients with stable disease may receive DLI at 9-12 months post-transplantation.

Regimen B

- Aggressive disease including:

- CML in accelerated phase or greater than first CR

- AML beyond first CR

- Myelodysplastic syndrome other than RARS

- Myeloma not in CR/PR

- Other NHL Patients receive oral cyclosporine twice daily beginning on day -3. If there is no evidence of GVHD, cyclosporine is tapered from day 56 until discontinuation by day 77. Beginning at least 2 weeks after the completion of cyclosporine, patients with persistent disease receive DLI IV over 30 minutes for up to 3 infusions.

Patients are followed at day 84, months 4, 6, 12, 18, and 24, and then annually thereafter.

PROJECTED ACCRUAL: A total of 160 patients (80 per risk group) will be accrued for this study within 3 years.

Study Design

Primary Purpose: Treatment

Conditions

Chronic Myeloproliferative Disorders

Intervention

therapeutic allogeneic lymphocytes, cyclosporine, fludarabine phosphate, mycophenolate mofetil, allogeneic bone marrow transplantation, peripheral blood stem cell transplantation, radiation therapy

Location

City of Hope Comprehensive Cancer Center
Duarte
California
United States
91010-3000

Status

Active, not recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:00-0400

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Medical and Biotech [MESH] Definitions

A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).

An enzyme of the transferase class that catalyzes the conversion of sedoheptulose 7-phosphate and D-glyceraldehyde 3-phosphate to D-ribose 5-phosphate and D-xylulose 5-phosphate in the PENTOSE PHOSPHATE PATHWAY. (Dorland, 27th ed) EC 2.2.1.1.

An enzyme of the transferase class that catalyzes the reaction sedoheptulose 7-phosphate and D-glyceraldehyde 3-phosphate to yield D-erythrose 4-phosphate and D-fructose phosphate in the PENTOSE PHOSPHATE PATHWAY. (Dorland, 27th ed) EC 2.2.1.2.

A critical subpopulation of regulatory T-lymphocytes involved in MHC Class I-restricted interactions. They include both cytotoxic T-lymphocytes (T-LYMPHOCYTES, CYTOTOXIC) and CD8+ suppressor T-lymphocytes.

Lymphocytes responsible for cell-mediated immunity. Two types have been identified - cytotoxic (T-LYMPHOCYTES, CYTOTOXIC) and helper T-lymphocytes (T-LYMPHOCYTES, HELPER-INDUCER). They are formed when lymphocytes circulate through the THYMUS GLAND and differentiate to thymocytes. When exposed to an antigen, they divide rapidly and produce large numbers of new T cells sensitized to that antigen.

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