Phase 2
N=254
A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Mantle Cell Lymphoma · Lymphoma, Mantle-Cell
Bottom Line
View on ClinicalTrials.gov: NCT00875667 ↗Enrolled (actual)
254
Serious AEs
38.8%
Results posted
Sep 2019
Primary outcome: Primary: Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review — 37.6; 22.7 weeks — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lenalidomide (Drug); Investigators choice single agent (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review |
37.6; 22.7 | 0.012 sig |
| PRIMARY Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis |
37.3; 23.6 | 0.003 sig |
| SECONDARY Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review |
40.0; 10.7 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis |
45.9; 22.6 | <0.001 sig |
| SECONDARY Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review |
69.6; 45.1 | 0.421 |
| SECONDARY Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis |
70.1; 91.7 | 0.875 |
| SECONDARY Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review |
69.4; 63.1 | 0.313 |
| SECONDARY Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis |
70.0; 65.5 | 0.465 |
| SECONDARY Kaplan Meier Estimate of Time to Progression According to the IRC Central Review |
39.3; 24.7 | 0.005 sig |
| SECONDARY Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis |
39.3; 24.7 | 0.003 sig |
| SECONDARY Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator |
24.4; 17.9 | 0.046 sig |
| SECONDARY Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis |
24.4; 17.9 | 0.095 |
| SECONDARY Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review |
18.7; NA | <0.001 sig |
| SECONDARY Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis |
23.9; 40.0 | <0.004 sig |
| SECONDARY Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review |
121.0; 91.7 | 0.519 |
| SECONDARY Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis |
120.6; 91.7 | 0.558 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
159; 69; 126; 49; 56; 29 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
71.8; 78.9; -0.5; -3.7; 1.6; -2.1 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit |
3.4; -1.8 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain |
71.5; 73.9; -4.8; 3.5; 1.4; -6.4 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit |
3.1; 5.0 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain |
84.6; 83.6; 0.0; -2.3; -1.9; 1.3 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit |
3.2; 2.9 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain |
74.9; 78.4; -1.0; -1.2; 1.6; -4.5 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit |
5.1; 3.8 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain |
40.2; 39.2; 0.1; 2.1; -3.2; 3.4 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit |
-4.9; -2.9 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain |
22.6; 13.7; -2.2; -1.2; -0.2; -2.6 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit |
-5.8; -3.5 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain |
4.9; 3.8; 2.5; 0.4; 2.6; 5.8 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit |
-2.3; -0.6 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Constipation |
12.5; 8.6; 6.3; -0.8; 4.2; 1.3 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit |
-0.3; -3.5 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea |
15.7; 12.6; -3.5; -3.1; -4.2; 1.3 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit |
-7.2; -5.8 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain |
29.4; 25.7; -7.6; -4.7; -5.2; -6.4 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit |
-12.8; -7.6 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit |
26.5; 21.2; -1.6; -0.8; -1.4; 0.0 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit |
-7.3; -5.8 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit |
18.1; 16.2; 2.5; -0.8; 1.9; 5.1 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit |
-4.8; -4.1 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit |
19.5; 10.8; -7.0; -0.8; -7.0; -3.8 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit |
-10.9; -2.3 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain |
59.0; 58.4; -3.4; 2.3; -0.7; 3.2 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit |
4.6; 5.6 | — |
| SECONDARY Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain |
73.7; 78.5; 3.4; 1.3; 3.6; 1.3 | — |
| SECONDARY Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit |
6.9; 3.7 | — |
Summary
To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven mantle cell lymphoma
- Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease
- Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2
- Willing to follow pregnancy precaution
Exclusion Criteria
- Any of the following laboratory abnormalities
- Absolute neutrophil count (ANC) 3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
- Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
- Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min
- History of active central nervous system (CNS) lymphoma within the previous 3 months
- Subjects not willing to take deep venous thrombosis (DVT) prophylaxis
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
Data sourced from ClinicalTrials.gov (NCT00875667). 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.