Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
NCT ID: NCT00425802
Last Updated: 2017-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2006-11-28
2016-10-28
Brief Summary
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PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).
anti-thymocyte globulin
filgrastim
graft-versus-tumor induction therapy
rituximab
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
nonmyeloablative allogeneic hematopoietic stem cell transplantation
total-body irradiation
Interventions
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anti-thymocyte globulin
filgrastim
graft-versus-tumor induction therapy
rituximab
cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
nonmyeloablative allogeneic hematopoietic stem cell transplantation
total-body irradiation
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Hugo R. Castro-Malaspina, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Juliet Barker, MBBS
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Craig Moskowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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References
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Sauter CS, Lechner L, Scordo M, Zheng J, Devlin SM, Fleming SE, Castro-Malaspina H, Moskowitz CH. Pretransplantation fluorine-18-deoxyglucose--positron emission tomography scan lacks prognostic value in chemosensitive B cell non-hodgkin lymphoma patients undergoing nonmyeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Jun;20(6):881-4. doi: 10.1016/j.bbmt.2014.02.009. Epub 2014 Feb 15.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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MSKCC-06150
Identifier Type: -
Identifier Source: secondary_id
06-150
Identifier Type: -
Identifier Source: org_study_id