Status:
COMPLETED
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
Lead Sponsor:
Celgene
Conditions:
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubic...
Detailed Description
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2022
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT02285062
Start Date
February 17 2015
End Date
July 28 2022
Last Update
June 22 2023
Active Locations (158)
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1
Local Institution - 177
Fayetteville, Arkansas, United States, 72703
2
Local Institution - 136
Orange, California, United States, 92868
3
Local Institution - 127
Sacramento, California, United States, 95817
4
Local Institution - 169
New Haven, Connecticut, United States, 06510