Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma (ROBUST)
|Lymphoma, Large B-Cell, Diffuse||Drug: lenalidomide Drug: Placebo Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: prednisone Drug: vincristine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma|
- Progression Free Survival [ Time Frame: Up to 5 years from the time the last patient is randomized ]Number of participants who survive without progressing
- Overall Survival [ Time Frame: Up to 5 years from the time the last patient is randomized ]Proportion of patients who survive
- Complete Response Rate [ Time Frame: Up to 5 years from the time the last patient is randomized ]Proportion of patients who have a complete response prior to any treatment change
- Duration of Complete Response [ Time Frame: Up to 5 years from the time the last patient is randomized ]Calculated only for patients who have a complete response. Time from the first complete response prior to treatment change to the first event of disease progression or death
- Time to Next Lymphoma Treatment [ Time Frame: Up to 5 years from the time the last patient is randomized ]Time from randomization to the time of treatment change to the next lymphoma treatment
- Objective Response Rate [ Time Frame: Up to 5 years from the time the last patient is randomized ]Proportion of patients who have either a complete or partial response before any treatment change
- Health Related Quality of Life [ Time Frame: Up to 5 years from the time the last patient is randomized ]Differences in health related quality of life will be compared between the two treatment groups
- Event Free Survival [ Time Frame: Up to 5 years ]Number of patients who survive without receiving a second anti-lymphoma treatment.
|Actual Study Start Date:||January 21, 2015|
|Estimated Study Completion Date:||September 30, 2022|
|Estimated Primary Completion Date:||June 30, 2018 (Final data collection date for primary outcome measure)|
lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
|Drug: lenalidomide Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: prednisone Drug: vincristine|
Active Comparator: R-CHOP
placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
|Drug: Placebo Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: prednisone Drug: vincristine|
This research study is for patients with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) of the activated B-cell (ABC) type who have not yet been treated. DLBCL is a cancer of a type of blood cell called B-lymphocytes. B lymphocytes are part of the body's immune system. There are different types of DLBCL. About a third of newly diagnosed DLBCL cancers are the ABC type. It has been observed that treatment does not work as well for patients with the ABC type compared to patients with other DLBCL types who receive standard treatment. However, at this time both ABC type and other DLBCL type patients receive the same standard treatments.
Patients with DLBCL who are otherwise healthy are usually treated first with the chemotherapy drug combination called R-CHOP. The drugs in this combination are "R" for rituximab, "C" for cyclophosphamide, "H" for doxorubicin which has a chemical name of hydroxydaunomycin, "O" for vincristine which has a trade name of oncovin, and "P" for prednisone. Depending on the local practice where you are treated, R-CHOP may be given for 6 or 8 cycles. A cycle could lasts for 14 or 21 days. The R-CHOP drug combination is approved for the treatment of DLBCL of all types, including ABC type. R-CHOP is standard care.
This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is not approved for use in DLBCL. Its use in this disease is experimental. In this study, the experimental treatment is lenalidomide + R-CHOP21 x 6.
This study will use a gene expression profile (GEP) test to see if a patient has the ABC type. The results of this GEP test affect whether you may be treated on this study. Because the performance of this test has not been proven, it is for investigational use only, and is still under development. This means the GEP test is an experimental test.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02285062
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|Study Director:||Lei Zhang, M.D||Celgene Corporation|