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Closed (no longer recruiting)Last updated: 16 January 2024

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

Clinical summary

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.

Conditions

This trial is treating patients with Diffuse Large Cell Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18 - 80

Phase

III

Trial Acronym

ROBUST

More information

Trial Identifiers

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Trial sponsor

Celgene Corporation

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

Eligibility

Inclusion

  1. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type
  2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
  3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  5. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status ≤ 1; and each organ system score ≤ 2 using cumulative illness rating scale (CIRS)

Exclusion

  1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma
  2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more
  3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
  4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2

Inclusion

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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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