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Complete title: A Phase 3, open-label, multicenter, randomized study of sequential Zevalin (ibritumomab tiuxetan) versus observation in patients at least 60 years of age with newly diagnosed diffuse large B-cell lymphoma in PET-negative complete remission after R-CHOP or R-CHOP-like therapy
|Research Study Number||7779|
|Principal Investigator||Ajay Gopal, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 1.Patient is 60-years of age or older at time of randomization
- 2.Histologically confirmed Ann Arbor stage II, III, or IV DLBCL; or FCL Grade 3B according to the REAL/WHO classification (from initial diagnosis made prior to starting R-CHOP therapy). Results from a pre R-CHOP marrow shall be available for review.
- 3.Local pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow upon confirmation of CR.
- 4.A paraffin block or original slides available for confirmatory pathology review. Patients may be randomized based on the local pathology result.
- 5.Age-adjusted IPI of 1, 2, or 3. The age adjusted IPI is defined by one point for LDH > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ECOG performance status >1.
- 6.First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or DA-EPOCH-R chemotherapy. Patients who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible.(See CRF Manual for further clarification).
- 7.Complete remission (CR) according to the International Workshop Response Criteria for NHL described by Cheson et al (Appendix 2). after first-line treatment. CT scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the patient had involvement of the neck region by palpation / physical examination at first diagnosis.
- 8.A negative FDG-PET scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale (Appendix 3) used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735).
- 9.Bone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for patients randomized to the Zevalin arm only.
- 10.A WHO/ECOG performance status of 0, 1 or 2.
- 11.Adequate hematopoietic functions: Absolute neutrophil count (ANC) => 1.0 x 109/L, Hemoglobin (Hgb) => 9 g/dL, Platelets => 100 x 109/L.
- 12.Life expectancy of 6 months or longer
- 13.Written informed consent obtained according to local guidelines
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 2.Prior radioimmunotherapy, including radiation therapy for NHL, or any other NHL therapy.
- 3.Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis.
- 4.Histological transformation of low-grade NHL.
- 5.Active hepatitis B or C. (See CRF completion manual)
- 6.Known history of HIV infection.
- 7.Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease.
- 8.Abnormal renal function: serum creatinine > 2.0 × ULN.
- 9.Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment.
- 10.Known hypersensitivity to murine or chimeric antibodies or proteins
- 11.G-CSF or GM-CSF therapy within 4 weeks prior to Zevalin or observation.
- 12.Concurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study.
- 13.Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation.
- 14.Major surgery less than 4 weeks prior to Zevalin or start of observation.
- 15.Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Patients on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20mg daily, stable for 4 weeks, are permissible.
- 16.Unwillingness or inability to comply with the protocol.
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)
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