Phase 3
N=570
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
Lymphoma, Large B-Cell, Diffuse
Bottom Line
View on ClinicalTrials.gov: NCT02285062 ↗Enrolled (actual)
570
Serious AEs
33.9%
Results posted
Mar 2020
Primary outcome: Primary: Kaplan-Meier Estimate of Progression Free Survival (PFS) — NA; NA months — p=0.2864
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lenalidomide (Drug); Placebo (Drug); Rituximab (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); prednisone (Drug); vincristine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of Progression Free Survival (PFS) |
NA; NA | 0.2864 |
| SECONDARY Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) |
NA; NA | 0.7294 |
| SECONDARY K-M Estimate of Overall Survival (OS) |
NA; NA | 0.8760 |
| SECONDARY Percentage of Participants Who Achieved a Complete Response (CR) |
69.1; 64.9 | 0.2933 |
| SECONDARY Percentage of Participants Who Achieved an Objective Response |
90.9; 90.9 | 0.9964 |
| SECONDARY K-M Estimate of Duration of Complete Response |
NA; NA | 0.2143 |
| SECONDARY K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) |
NA; NA | 0.3150 |
| SECONDARY Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire |
98.6; 98.2; 87.0; 86.3; 76.1; 79.6 | — |
| SECONDARY Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire |
98.9; 97.9; 87.0; 86.3; 76.5; 79.6 | — |
| SECONDARY Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale |
-0.7; 0.2; -0.0; 0.9; 1.5; 0.7 | — |
| SECONDARY Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale |
3.8; 4.1; 5.8; 5.2; 6.6; 4.5 | — |
| SECONDARY Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale |
-0.5; 0.5; 0.0; 1.4; 1.0; 0.7 | — |
| SECONDARY Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI) |
2.6; 4.6; 5.9; 7.5; 9.1; 5.8 | — |
| SECONDARY Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score |
0.08; 0.08; 0.10; 0.14; 0.10; 0.06 | — |
| SECONDARY Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS) |
4.0; 3.0; 6.0; 9.0; 8.0; 6.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02285062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.