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

Plain-language summary

This study compares Lenalidomide plus R-CHOP chemotherapy with placebo plus R-CHOP in patients with newly diagnosed, untreated activated B-cell (ABC) type diffuse large B-cell lymphoma. It included patients aged 18-80 with confirmed ABC-type DLBCL. It was a Phase 3 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Celgene

Intervention

lenalidomide, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, prednisone, vincristine

Start date

2/17/2015

Estimated completion

7/28/2022

Countries

United States, Australia, Belgium, Canada, China, Czechia, France, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Portugal, Puerto Rico, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye)

Related genes

Locations

• Fayetteville, United States
• Orange, United States
• Sacramento, United States
• New Haven, United States
• Hollywood, United States
• Ames, United States
• Sioux City, United States
• Fairway, United States
• Shreveport, United States
• Bethesda, United States
• Minneapolis, United States
• Minneapolis, United States
• Rochester, United States
• Durham, United States
• Philadelphia, United States
• Dallas, United States
• Dallas, United States
• Salt Lake City, United States
• Edmonds, United States
• Issaquah, United States
• Seattle, United States
• Seattle, United States
• Albury, Australia
• Clayton, Australia
• Geelong, Australia
• Frankston, Australia
• Brussels, Belgium
• Liège, Belgium
• Roeselare, Belgium
• Sint-Niklaas, Belgium
• Calgary, Canada
• Surrey, Canada
• Saint John, Canada
• Greenfield Park, Canada
• Montreal, Canada
• Beijing, China
• Beijing, China
• Beijing, China
• Beijing, China
• Changchun, China

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

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 Criteria:

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