A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes in Conjunction With Rituximab for Selected Patients With CD20 + Malignancies
Inclusion Criteria
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