A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). (RENEW)
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Purpose
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).
This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma Non-Hodgkin's Lymphoma |
Drug: Lenalidomide Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma |
- Progression-free Survival (PFS) [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.
Study terminated prematurely. Analysis not conducted.
- Overall Survival [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
Overall survival was defined as the time from randomization to death from any cause.
Study terminated prematurely. Analysis not conducted.
- Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: up to 9 months ] [ Designated as safety issue: Yes ]
Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.
The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.
- Time to Progression [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.
Study terminated prematurely. Analysis not conducted.
- Time to Treatment Failure [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.
- Participants With a Tumor Response [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Study terminated prematurely. Analysis not conducted.
| Enrollment: | 9 |
| Study Start Date: | April 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lenalidomide
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
|
Drug: Lenalidomide
15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Other Name: Revlimid
|
|
Experimental: Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
|
Other: Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically-proven mantle cell non-Hodgkin's lymphoma,
- One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
- Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
- ECOG performance status score of ≤ 2
- Willing to follow pregnancy precaution
Exclusion Criteria:
- Patients who have received more than 1 line of induction chemotherapy;
- Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
- Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L)
- Platelet count < 60,000/mm^3 (60*10^9/L)
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
- Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
- Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min
- Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
- Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
Contacts and Locations
Show 92 Study Locations| Principal Investigator: | Martin Dreyling, Prof. Dr | Medizinische Klinik III der Universität München |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01021423 History of Changes |
| Other Study ID Numbers: | CC-5013-MCL-003 |
| Study First Received: | November 25, 2009 |
| Results First Received: | October 31, 2011 |
| Last Updated: | February 10, 2012 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Russia: Ministry of Health of the Russian Federation Spain: Spanish Agency of Medicines Switzerland: Swissmedic |
Keywords provided by Celgene Corporation:
|
Mantle Cell Lymphoma Non-Hodgkin's Lymphoma CC-5013 Revlimid Lenalidomide |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lenalidomide Thalidomide Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013