CompletedPhase 3

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

United States570 participantsStarted 2015-02-17

Plain-language summary

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type
✓. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
✓. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
✓. 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 criteria

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

What they're measuring

Kaplan-Meier Estimate of Progression Free Survival (PFS)

Timeframe: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months

Trial details

NCT IDNCT02285062

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-15

Results submitted2020-03-13

View on ClinicalTrials.gov More Lymphoma, Large B-Cell, Diffuse trials