Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) in Elderly (More Than 60 Years) Patients With Diffuse Large B Cell Lymphoma After 4 Cycles of CHOP21-Rituximab (CHOP21-R) Therapy
Lead Sponsor:
University of Bologna
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan ("Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to t...
Eligibility Criteria
Inclusion
- Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP21-R therapy);
- Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence/evidence with an infiltration \<25% of DLBCL in bone marrow;
- The first part of the treatment of DLBCL must have been 4 cycles of standard CHOP21 chemotherapy (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and at least 40 mg/m2/day prednisone on Days 1 to 5 every three weeks) in combination with rituximab (375 mg/m2);
- Complete remission (CR), unconfirmed complete remission (CRu), partial response, and non-responder according to the International Workshop Response Criteria for NHL described by Cheson et al (18) after four cycles of CHOP21-R. CT scans of the neck, thorax, abdomen, and pelvis and PET total body must have been performed within 3 weeks after the last dose of the last course of CHOP21-R;
- Patients 60-years-of-age or older at time of accrual;
- WHO performance status (PS) of 0 to 2 within 1 week of accrual;
- Absolute neutrophil count (ANC) more than 1.5 x 109/L within 1 week of accrual;
- Hemoglobin (Hgb) more than 10 g/dL within 1 week of accrual;
- Platelets more or equal than 150 x 109/L within 1 week of accrual.
- Life expectancy of 3 months or longer
- Written informed consent obtained according to local guidelines
Exclusion
- Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma;
- Prior radioimmunotherapy, radiation therapy, or any other NHL therapy;
- Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis;
- Histological transformation of low-grade NHL;
- Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg);
- Known history of HIV infection;
- Abnormal liver function: total bilirubin \> 1.5 x ULN or ALT \> 2.5 x ULN within 1 week of accrual;
- Abnormal renal function: serum creatinine \> 2.0 x ULN within 1 week of accrual;
- Nonrecovery from the toxic effects of CHOP21-R therapy;
- Known hypersensitivity to murine or chimeric antibodies or proteins;
- G-CSF or GM-CSF therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling;
- Concurrent severe and/or uncontrolled medical 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;
- Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy;
- Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery;
- Concurrent 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;
- Unwillingness or inability to comply with the protocol.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00850512
Last Update
February 25 2009
Active Locations (1)
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1
Istituto di Ematologia e Oncologia Medica Seràgnoli
Bologna, BO, Italy, 40138