Rituximab, Fludarabine, Cyclophosphamide, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed B-Cell Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, Waldenstrom macroglobulinemia, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
Indolent NHL, including any of the following:
- Follicular
- Lymphoplasmacytoid
- Marginal zone
- Mantle cell NHL
- Transformed B-cell NHL
In at least first relapse with an indication for systemic antineoplastic treatment, as defined by the following:
- Local or constitutional (B-) symptoms
- Hypersplenism due to splenic involvement
- Bulky disease (> 7.5 cm in diameter)
- Impending medical problems derived from rapid disease progression within the past 6 months, as defined by an observed or anticipated > 50% increase in the sum of the areas calculated from multiplying the greatest perpendicular diameters of each lesion
- Measurable lesions of lymphoma infiltration
- Medically ineligible for high-dose treatment followed by autologous stem cell support
- Adequate bone marrow cellularity (> 15% of marrow area covered by hematopoiesis)
- No CNS, leptomeningeal, spinal cord, or testes lymphoma involvement
- No lymphoma lesion mandating emergency radiotherapy
- No clinical, cytological, cytogenetic, or histopathologic indication of myelodysplastic syndrome
- If there is bone marrow infiltration detected prior to chemoimmunotherapy, patient must undergo a repeat bone marrow biopsy prior to planned treatment with radioimmunotherapy to verify the level of bone marrow infiltration is < 25%
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 150,000/mm³
- Hemoglobin > 9 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
- Bilirubin < 2 times ULN
- ALT and AST < 2 times ULN
- Albumin > 2.5 g/dL
- INR < 1.5
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 12 months after completion of study treatment
No concurrent severe and/or uncontrolled medical disease that would preclude study compliance, including any of the following:
- Uncontrolled diabetes
- Congestive heart failure
- Chronic renal disease
- Active uncontrolled infection
No bleeding risks or disorders, including any of the following:
- CNS abnormalities suggesting an increased susceptibility for hemorrhage, including recent history of stroke as demonstrated by cranial contrast-enhanced CT scan
- Severe arrhythmia or uncontrolled hypertension
- Myocardial infarction within the past 6 months
- Diabetic retinopathy with history of symptomatic hemorrhage
- Known and potentially active gastrointestinal bleeding foci
- Concurrent anticoagulant medication that must be continued even with platelet count < 20,000/mm³ (e.g., following mitral valve replacement, anti-phospholipid syndrome, or recurrent venous thromboembolism)
- Other congenital or acquired hemorrhagic diatheses
- No ongoing autoimmune hemolytic anemia
- No known presence of anti-murine antibody reactivity
- No known hypersensitivity to murine or chimeric antibodies or proteins
- No known HIV infection
- No psychiatric illness that would preclude study requirements
- No other malignant disorder within the past 10 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- No more than 4 prior systemic anti-lymphoma regimens (including single-agent rituximab)
- At least 2 months since prior systemic anti-lymphoma treatment (including single-agent rituximab)
- No prior radioimmunotherapy
- No prior autologous or allogeneic hematopoietic stem cell transplantation
- No prior treatment with purine analogues that has not resulted in remission for > 1 year
- No prior anti-CD20 radioimmunoconjugate therapy
- More than 5 years since prior radiotherapy to extensive fields covering lymph node regions on both sides of the diaphragm or > 50% of the spinal column
- More than 4 weeks since prior surgery
- No concurrent oral anticoagulant therapy
Sites / Locations
- Medizinische Klinik, Klinikum Augsburg
- Medizinische Klinik III - Universitaetsklinikum Erlangen
- Universitaetsklinikum Goettingen
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- Universitatsklinik Mainz
- LMU-Klinikum Grosshadern
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Klinikum der Universitaet Regensburg
- Universitaetsklinikum Tuebingen
- Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
- Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg