EUCTR2005-001727-11-SEActive, not recruitingNot Applicable
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
Bayer AB, Bayer Health Care, Bayer Schering Pharma0 sites400 target enrollmentStarted: March 2, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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
- •5.Central radiographic review of the CT scans (chest, abdomen, pelvis, and neck if applicable) 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 10^9/L within 1 week of randomization
- •9.Hemoglobin (Hgb) >= 10 g/dL within 1 week of randomization
- •10.Platelets >= 150 x 10^9/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
Investigators
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