Status:
COMPLETED
Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from re...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- CD20-positive aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
- Diffuse large cell lymphoma\*, meeting 1 of the following criteria:
- Relapsed disease after initial therapy, but failed to mobilize or had bone marrow involvement and therefore is not suitable for an autologous stem cell transplantation
- High-intermediate- or high-risk second-line, age-adjusted International Prognostic Index score and in second complete remission (CR) or partial remission (PR) after autologous stem cell transplantation
- Failed prior autologous stem cell transplantation and in PR or better after salvage chemotherapy
- Large cell transformation of indolent NHL or chronic lymphocytic leukemia (CLL), meeting the following criteria:
- In CR or PR of the large cell component of disease after salvage chemotherapy or autologous stem cell transplantation
- Mantle cell lymphoma\*, meeting 1 of the following criteria:
- High-risk disease (e.g., p53 positivity) and in first CR or PR after initial therapy
- Relapsed disease after initial therapy and in second or third CR or PR after salvage chemotherapy NOTE: \*No progressive disease at allograft work-up
- CD20-positive indolent NHL (e.g., follicular lymphoma, small cell lymphoma, or marginal zone NHL) OR CLL
- Second or subsequent progression (pre-allograft cytoreduction necessary, but CR or PR not required)
- Relapsed disease must be biopsy-proven
- Must have received pre-allograft salvage chemotherapy, including 1 of the following:
- Single autologous stem cell transplantation using high-dose chemotherapy conditioning within the past 120 days
- At least 2 courses of intensive combination chemotherapy (e.g., RICE \[rituximab, ifosfamide, carboplatin, etoposide\]), according to diagnosis, within the past 80 days
- CLL patients who have received CAMPATH do not have to receive pre-allograft salvage chemotherapy
- HLA-compatible related or unrelated donor available
- HLA-matched ≥ 9/10 of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution typing
- One allele mismatch allowed
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Creatinine \< 1.2 mg/mL OR creatinine clearance ≥ 50 mL/min
- Bilirubin \< 2.5 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (unless benign congenital hyperbilirubinemia is present)
- Spirometry and corrected DLCO ≥ 50% of normal
- LVEF ≥ 40%
- Albumin ≥ 2.5 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled infection, including active infection with Aspergillus or other mold
- No HIV infection
- No hepatitis B antibody or antigen positivity
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior allogeneic transplantation
Exclusion
Key Trial Info
Start Date :
November 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2016
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00425802
Start Date
November 28 2006
End Date
October 28 2016
Last Update
October 31 2017
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065