ROBUST : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18 - 75Age 18 - 75

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaDiffuse Large Cell Lymphoma,

Trial Overview Read MoreRead more

This phase III trial is adding lenalidomide to standard R-CHOP chemotherapy (R2-CHOP) for the treatment of Diffuse Large Cell Lymphoma.
 

This trial is treating patients with Diffuse Large Cell Lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Celgene Corporation

Summary

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 last 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. In this study, R-CHOP is given for 6 cycles. Each cycle will last 21 days. It is called R-CHOP21 x 6. In this study, the standard treatment is R-CHOP21 x 6. 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.

Recruiting Hospitals Read MoreRead more

Austin Hospital
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Border Medical Oncology
Albury
Ms Kate Rooney
krooney@bordermedonc.com.au
02 6064 1503

Frankston Hospital
Frankston
Ms Judi Clarke
jclarke@phcn.vic.gov.au
03 9784 8301

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Monash Medical Centre Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

Not Recruiting Hospitals Read MoreRead more

Closed

Bendigo Hospital
Bendigo
Ms Amanda Rundle
arundle@bendigohealth.org.au
03 5454 8821

PCCTU (Parkville cancer clinical trials unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182