IRB #

IRB00011800

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 = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

Principal Investigator

Stephen Spurgeon

Study Purpose

The purpose of this study is to compare any good and bad effects of using a different regimen of drugs not yet approved by the FDA. Different regimens of bedamustine, rituximab, bortezomib, and lenalidomide could shrink your cancer or prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the new regimens of drugs should increase life by six months or more compared to the usual approach.
These regimens are experimental and have not been approved by the FDA for use in participants with untreated mantle cell lymphoma, although each of the drugs used in the study is FDA approved for certain blood cancers.

Medical Condition(s)

Mantle Cell Lymphoma

Eligibility Criteria

-18 years of age or older.
-Females of childbearing potential must not be pregnant or breastfeeding
due to risk of fetal harm by the chemotherapeutic agents
prescribed in this protocol.
-No prior therapy for Mantle cell lymphoma
-Patient must have no CNS involvement
-Patients must have at least one objective measurable disease
parameter.
-ECOG performance between 0-2.
-No prior evidence of malignancy except adequately treated non-melanoma skin cancer.
-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.
-Patients must not have a serious medical or psychiatric illness that may interfere with participation in the study.
-Patients must not be participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration.

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression or complete response to treatment

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

National Cancer Institute

Recruitment End

01/01/2030

Compensation Provided

No


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