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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lymphoma, Large B-Cell, Diffuse

In brief

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.

Key facts

Study ID

NCT02285062

Run by

Celgene

People needed

570

Starts

2015-02-17

Expected to finish

2022-07-28

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Local Institution - 136 — Orange, California, United States
• Local Institution - 127 — Sacramento, California, United States
• Local Institution - 169 — New Haven, Connecticut, United States
• Local Institution - 128 — Hollywood, Florida, United States
• McFarland Clinic — Ames, Iowa, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Local Institution - 143 — Fairway, Kansas, United States
• Local Institution - 158 — Shreveport, Louisiana, United States
• Center For Cancer And Blood Disorders — Bethesda, Maryland, United States
• Local Institution - 101 — Minneapolis, Minnesota, United States
• Local Institution - 138 — Minneapolis, Minnesota, United States
• Local Institution - 112 — Rochester, Minnesota, United States
• Local Institution - 103 — Durham, North Carolina, United States
• Local Institution - 161 — Philadelphia, Pennsylvania, United States
• Local Institution - 951 — Dallas, Texas, United States
• Local Institution - 151 — Dallas, Texas, United States
• Local Institution - 146 — Salt Lake City, Utah, United States
• Local Institution - 905 — Edmonds, Washington, United States
• Local Institution - 903 — Issaquah, Washington, United States
• Local Institution - 162 — Seattle, Washington, United States
• Local Institution - 904 — Seattle, Washington, United States
• Local Institution - 004 — Albury, New South Wales, Australia
• Local Institution - 008 — Clayton, Victoria, Australia
• Local Institution - 002 — Geelong, Victoria, Australia
• Local Institution - 177 — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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