Enrollment complete
Intergroup Randomized Phase II Four Arm Study in Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab + Bendamustine Followed By Rituximab Consolidation (RB ? R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV ? R), Arm C ...
NCT No.: NCT01415752
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: Colorado
Acronym:
Official Title
Intergroup Randomized Phase II Four Arm Study in Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab + Bendamustine Followed By Rituximab Consolidation (RB ? R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV ? R), Arm C ...
Purpose
PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
Detailed Description
Eligibility Criteria
Inclusion Criteria
|
Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH);
Patients must have at least one objective measurable disease parameter
Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
Measurable disease in the liver is required if the liver is the only site of lymphoma;
ECOG performance status 0-2;
ANC = 1,500/mcL (1.5 x 10^9/L)*;
Platelets = 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.
|
Exclusion Criteria
|
Patient must have no CNS involvement;
No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for = 5 years so as not to interfere with interpretation of radiographic response;
Patients must not have grade 2 or greater peripheral neuropathy;
Patients must not have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia;
Patients must not have hypersensitivity to bortezomib, boron, or mannitol
|
Keywords and/or Specific Medical Conditions
Sponsors
- Eastern Cooperative Oncology Group
|
|