Phase 3
N=111
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse Large B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01197560 ↗Enrolled (actual)
111
Serious AEs
67.0%
Results posted
Aug 2014
Primary outcome: Primary: Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC) — 27.5; 11.8; 26.1; 12.0 percentage of participants — p=0.079
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lenalidomide (Drug); Gemcitabine (Drug); Oxaliplatin (Drug); Rituximab (Drug); Etoposide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Percentage of Participants With an Overall Response According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 and Evaluated by the Independent Response Adjudication Committee (IRAC) |
27.5; 11.8; 26.1; 12.0; 28.6; 11.5 | 0.079 |
| PRIMARY Stage 1: Percentage of Participants With an Overall Response According to the IWG Response Criteria Based on the Investigators Assessment at the Final Data Cut During the Core Treatment Phase |
29.4; 13.7 | 0.091 |
| SECONDARY Number of Participants With Treatment Emergent Events (TEAEs) in the Overall Treatment Phase by Initial Treatment Assignment |
54; 55; 49; 45; 43; 53 | — |
| SECONDARY Stage 2: Overall Response Rate (ORR) |
— | — |
| SECONDARY Stage 2: Duration of Response (DoR) |
— | — |
| SECONDARY Stage 2: Overall Survival (OS) |
— | — |
| SECONDARY Stage 2: Duration of Complete Response |
— | — |
| SECONDARY Stage 2: Overall Response Rate for With a Duration of Response Lasting ≥ 16 Weeks |
— | — |
| SECONDARY Stage 2: Time to Progression |
— | — |
| SECONDARY Stage 2: Health Related Quality of Life Questionnaires |
— | — |
Summary
The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
Eligibility Criteria
Inclusion Criteria
- Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
- Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.
- Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Exclusion Criteria
- Diagnosis of lymphoma histologies other than DLBCL.
- History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.
- Eligible for autologous stem cell transplant.
- Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)
- Neuropathy grade 4.
Data sourced from ClinicalTrials.gov (NCT01197560). 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.