Status:
COMPLETED
Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
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, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the gro...
Detailed Description
OBJECTIVES: Primary * Determine the overall and event-free survival at 1 year in patients with B-cell lymphoid malignancies treated with a nonmyeloablative conditioning regimen, rituximab, and umbil...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- CD20+\* aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following:
- Diffuse large cell (DLC) NHL 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 (IPI) score and in second complete remission (CR) or partial remission (PR) after prior autologous stem cell transplantation
- Failed prior autologous stem cell transplantation and in at least PR after salvage chemotherapy
- Large cell transformation of indolent NHL/chronic lymphocytic leukemia (CLL) meeting the following criteria:
- CR/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, as defined by p53 positivity and in first CR/PR after initial therapy
- Relapsed disease after initial therapy and in second or third CR/PR after salvage chemotherapy
- CD20+\* indolent NHL or CLL meeting the following criteria:
- Must be in second or subsequent progression (pre-allograft cytoreduction necessary but CR/PR not required)
- Indolent NHL includes, but is not limited to, any of the following:
- Follicular NHL
- Small cell NHL
- Marginal zone NHL NOTE: \*CD20 positivity must be demonstrated within the past 12 months
- Relapsed disease must be biopsy proven
- Prior pre-allograft cytoreduction may have included 1 of the following:
- Single autologous stem cell transplantation with high-dose chemotherapy conditioning, if appropriate, and no conditioning prior to transplantation
- Two or more courses of intensive combination chemotherapy (e.g., rituximab, irinotecan hydrochloride, cetuximab, epirubicin hydrochloride \[RICE\]) as appropriate according to diagnosis and prior therapy
- Heavily pre-treated CLL patients in whom further combination chemotherapy is not appropriate may receive single-agent intermediate-dose cyclophosphamide for 2-3 courses
- No mantle cell or DLC NHL with progressive disease at allograft work-up
- No suitable matched related or unrelated donor available
- Two umbilical cord blood (UCB) units available meeting the following criteria:
- Units and recipient must be ≥ 4/6 HLA-A and -B antigen and DRB1 allele matched
- Each unit must have ≥ 1.5 x 10\^7 total nucleated cells/recipient body weight
- PATIENT CHARACTERISTICS:
- Karnofsky performance score 70-100%
- Creatinine clearance ≥ 50 mL/min
- Bilirubin \< 2.5 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (unless due to benign congenital hyperbilirubinemia)
- Spirometry and corrected DLCO ≥ 50% normal
- LVEF ≥ 40%
- Albumin ≥ 2.5 g/dL
- No active and uncontrolled infection at time of transplantation, including active infection with Aspergillus or other mold
- No HIV positivity
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 120 days since prior autologous stem cell transplantation
- No more than 60 days since prior chemotherapy
- No prior allogeneic transplantation
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00387959
Start Date
July 1 2006
End Date
April 1 2014
Last Update
February 1 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065