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)

This study has been terminated.
(Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01021423
First received: November 25, 2009
Last updated: February 10, 2012
Last verified: February 2012

November 25, 2009
February 10, 2012
April 2010
March 2011   (final data collection date for primary outcome measure)
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.

Progression-free survival (PFS) [ Time Frame: Until 80% of subjects have died or 5 years after last subject randomized ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021423 on ClinicalTrials.gov Archive Site
  • 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.

  • Overall survival [ Time Frame: Until 80% of subjects have died or 5 years after last subject randomized ] [ Designated as safety issue: No ]
  • Safety assessments [ Time Frame: Throughout the study until 30 days post last dose of study drug ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: Until 80% of subjects have died or 5 years after last subject randomized ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Throughout the treatment period (maximum 2 years) ] [ Designated as safety issue: No ]
  • Tumor response (improvement in response from PR to CR and proportion of patients with measurable tumor at time of randomization who achieve CR) [ Time Frame: Until 80% of subjects have died or 5 years after last subject randomized ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • 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
  • 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.
  • 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.
    Intervention: Drug: Lenalidomide
  • 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.
    Intervention: Other: Placebo
Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
March 2011
March 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   France,   Germany,   Israel,   Italy,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom
 
NCT01021423
CC-5013-MCL-003
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Principal Investigator: Martin Dreyling, Prof. Dr Medizinische Klinik III der Universität München
Celgene Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP