Comparison of Fludarabine Plus Total-Body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL |
| Study Start Date: | October 2001 |
OBJECTIVES:
- Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions.
- Compare the toxic effects of these regimens in these patients.
- Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens.
- Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens.
- Compare the efficacy of these treatment regimens, in terms of 1-year disease-free survival, of these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease, age (less than 55 vs over 55), and participating transplantation center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28.
- Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150.
At approximately day 180, patients with persistent disease, evidence of T-cell chimerism, and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.
Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every 6 months for 1 year.
Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia OR
Diagnosis of non-Hodgkin's lymphoma
- Lymphoplasmacytic lymphoma
- Grade I follicular small cleaved cell lymphoma
- Grade II follicular mixed cell lymphoma
- Diffuse small cleaved cell lymphoma
- Small lymphocytic lymphoma
- Relapsed after at least 1 course of prior therapy
- Availability of a 6/6 HLA A, B, and DR identical sibling donor
- Nonmyeloablative transplantation candidate
- No clinically significant effusions or ascites that would preclude administration of methotrexate
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy:
- At least 6 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 3 mg/dL
Renal:
- Creatinine no greater than 2 mg/dL
Cardiovascular:
- LVEF at least 40% on MUGA scan or echocardiogram
Pulmonary:
- DLCO at least 50% of predicted
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled bacterial, viral, fungal, or parasitic infection
- HIV1 and HIV2 negative
- No other active malignancy except basal cell skin cancer
- No recent history of drug or alcohol abuse
- No other primary disease or comorbid illness that would severely limit life expectancy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- Prior autologous bone marrow transplantation allowed if disease has progressed after transplantation
- No entry on study as part of a tandem autologous transplantation followed by nonmyeloablative allograft protocol
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations
Show 23 Study Locations| Study Chair: | Robert H. Collins, MD | Simmons Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00041288 History of Changes |
| Other Study ID Numbers: | CDR0000069462, UTSMC-0501228, AMGEN-UTSMC-0501228, IBMTR-SC-00-02.1, ROCHE-UTSMC-0501228, SPRI-UTSMC-0501228, NCI-V02-1706 |
| Study First Received: | July 8, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
Waldenstrom macroglobulinemia refractory chronic lymphocytic leukemia recurrent grade 1 follicular lymphoma |
recurrent grade 2 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent small lymphocytic lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Cyclosporins Cyclosporine |
Methotrexate Mycophenolate mofetil Fludarabine monophosphate Tacrolimus Fludarabine Mycophenolic Acid Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on May 16, 2013