A phase III, open-label, prospective, two-armed, multicenter, randomized,group sequential study to evaluate the efficacy and safety of subsequenttreatment with the Zevalin (ibritumomab tiuxetan) study regimen versusobservation in patients with diffuse large B-cell lymphoma who are incomplete remission after first-line CHOP-rituximab (CHOP-R) therapy - Zevalin in aggressive lymphoma (DLBCL) phase III

Conditions: Diffuse large B-cell lymphoma

Registration Number: EUCTR2005-001727-11-IE

Lead Sponsor: Schering AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1.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)
2.Central pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow
3.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) in combination with rituximab (375 mg/m2)
4.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 the neck, thorax, abdomen, and pelvis must have been performed within 6 weeks after the last dose of the last course of CHOP R
5.Central radiographic review of the CT scans (neck, thorax, abdomen, and pelvis) from before and after first-line treatment with CHOP-R fulfilling the radiological requirements for CR/CRu
6.Patients 60-years-of-age or older at time of randomization
7.WHO performance status (PS) of 0 to 2 within 1 week of randomization
8.Absolute neutrophil count (ANC) >= 1.5 x 109/L within 1 week of randomization
9.Hemoglobin (Hgb) >= 10 g/dL within 1 week of randomization
10.Platelets >= 150 x 109/L within 1 week of randomization
11.Life expectancy of 3 months or longer
12.Written informed consent obtained according to local guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
2.Prior radioimmunotherapy, radiation therapy, or any other NHL therapy except first-line CHOP-R
3.Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis
4.Histological transformation of low-grade NHL
5.Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg)
6.Known history of HIV infection
7.Abnormal liver function: total bilirubin > 1.5 x ULN or ALT > 2.5 x ULN within 1 week of randomization
8.Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of randomization
9.Nonrecovery from the toxic effects of CHOP-R therapy
10.Known hypersensitivity to murine or chimeric antibodies or proteins
11.G-CSF or GM-CSF therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling
12.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
13.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
14.Female patients who are pregnant or are currently breastfeeding
15.Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy
16.Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery
17.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
18.Unwillingness or inability to comply with the protocol