This trial is active, not recruiting.

Condition lymphoma, large cell, diffuse
Treatments zevalin therapeutic regimen, observation
Phase phase 3
Sponsor CTI BioPharma
Collaborator Bayer
Start date May 2006
End date December 2009
Trial size 400 participants
Trial identifier NCT00322218, 307940/106-20


This study will treat patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with CHOP-R. Half of the patients will receive Zevalin and the other half will receive no further anti-cancer treatment. The two patient groups will be compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP R.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Zevalin Therapeutic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
zevalin therapeutic regimen
Zevalin Therapeutic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin

Primary Outcomes

Overall survival
time frame: Collected until a subject dies (any cause), is lost to follow-up, or withdraws consent.

Secondary Outcomes

Disease-free survival
time frame: Collected until a subject relapses as assessed by an Investigator, dies (any cause), is lost to follow-up, or withdraws consent.
Health-related quality of life
time frame: Will be assessed during the safety period and and yearly during the follow-up period for 3 years

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP-R therapy) - Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow - First-line treatment of DLBCL must have been 6 or 8 cycles of standard CHOP 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, with generally accepted adjustments in dose or frequency due to toxicity, patient scheduling, etc.) in combination with rituximab (375 mg/m2) - Complete remission (CR) or unconfirmed complete remission (CRu) according to the International Workshop Response Criteria for NHL described by Cheson et al and modified for this study after first-line treatment with CHOP-R. 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 CHOP-R. Applicability of the neck CT means that the patient had involvement of the neck region by palpation / physical examination at first diagnosis (pre-CHOP-R). - Central radiographic review of the CT scans (chest, abdomen, pelvis and if applicable, neck) from before and after first-line treatment with CHOP-R fulfilling the radiological requirements for CR/CRu - Patients 60 years of age or older at time of randomization - WHO performance status (PS) of 0 to 2 within 1 week of randomization - Absolute neutrophil count (ANC)greater than or equal to 1.5 x 10^9/L within 1 week of randomization - Hemoglobin (Hgb) greater than or equal to 10 g/dL within 1 week of randomization - Platelets greater than or equal to 150 x 10^9/L within 1 week of randomization - Life expectancy of 3 months or longer - Written informed consent obtained according to local guidelines Exclusion Criteria: - 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 except first-line CHOP-R - 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 randomization - Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of randomization - Nonrecovery from the toxic effects of CHOP-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 - Male and female patients of child-bearing potential unwilling to practice effective contraception during the study and unwilling or unable to continue contraception for 12 months after their last dose of study treatment - Female patients who are pregnant or are currently breastfeeding - 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 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 - Unwillingness or inability to comply with the protocol

Additional Information

Official title A Phase III, Open-Label, Prospective, Two-Armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study Regimen Versus Observation in Patients With Diffuse Large B-Cell Lymphoma Who Are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by CTI BioPharma.