Status:
TERMINATED
Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed lymphoproliferative disease
- CD20-positive disease
- Bidimensionally measurable disease OR abnormal cells detected in blood
- Resistant or refractory to standard therapies and/or unlikely to benefit from additional standard therapies\* AND meets 1 of the following criteria:
- Disease with anticipated response rate \< 20% after treatment with rituximab alone, including any of the following:
- Diffuse large cell lymphoma
- B-cell lymphoblastic lymphoma
- Burkitt's lymphoma
- Acute lymphocytic leukemia
- Relapsed or progressive disease after prior treatment with rituximab, including any of the following:
- Hodgkin's lymphoma
- Hairy cell leukemia
- Chronic lymphocytic leukemia/small lymphocytic lymphoma meeting any of the following criteria:
- Received prior fludarabine phosphate-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
- Received prior anti-CD52 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
- Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
- B-cell prolymphocytic leukemia meeting any of the following criteria:
- Received prior fludarabine phosphate- or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
- Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
- Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:
- Received prior fludarabine phosphate- and/or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
- Received prior anti-CD20 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy
- Received prior radioconjugated anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy
- Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
- Multiple myeloma meeting any of the following criteria:
- Received prior alkylating agent-, thalidomide-, corticosteroid-, or bortezomib-containing regimens and relapsed after 1 year of treatment OR ineligible to receive such therapies due to comorbidities or allergies
- Received prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
- Mantle cell lymphoma meeting the following criteria:
- Received prior combination chemotherapy and anti-CD20 monoclonal antibody therapy and relapsed after treatment OR ineligible to receive such therapy
- Diffuse large B-cell lymphoma meeting any of the following criteria:
- Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
- Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR not a candidate to receive such therapy
- Received prior radiolabeled anti-CD20 monoclonal antibody therapy for transformed large cell lymphoma OR ineligible to receive such therapy
- Burkitt's lymphoma meeting any of the following criteria:
- Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
- Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
- Lymphomatoid granulomatosis meeting any of the following criteria:
- Received prior single-agent or combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
- Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
- Acute lymphocytic leukemia meeting any of the following criteria:
- Received prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses and relapsed during or after treatment OR ineligible to receive such therapy
- Received prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplantation (HSCT) and relapsed after treatment OR not a candidate for such therapy
- Received prior treatment with chemotherapy with or without radiotherapy followed by allogeneic HSCT and relapsed after treatment (or not a candidate for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization, or molecular (reverse transcriptase-polymerase chain reaction) evidence of the bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate NOTE: \*Not eligible to receive standard available salvage regimens anticipated to result in durable remission
- No active CNS malignancy
- Not considered a candidate for allogeneic HSCT
- HLA-partially matched (≥ 2/6) related donor available
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy \> 3 months
- Not pregnant
- Negative pregnancy test
- Fertile women must use effective contraception
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- AST \< 3.0 times ULN
- Cardiac ejection fraction \> 35%
- Absolute neutrophil count \> 1,000/mm³ (without cytokines)
- Platelet count \> 50,000/mm³ (untransfused)
- No significant organ dysfunction
- No active uncontrolled infections
- No hypersensitivity reaction to rituximab that has precluded completion of a 4-week course of rituximab therapy
- No uncontrolled psychiatric illness or medical condition that would preclude tolerance of study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy for at least 7 days
- More than 30 days since prior cytotoxic chemotherapy
- At least 14 days since prior steroids
- At least 14 days since prior radiotherapy to non-target lesions
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00176475
Start Date
January 1 2005
End Date
February 1 2008
Last Update
September 17 2013
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903