A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (Sprint)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00875667
First received: April 1, 2009
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory Mantle Cell Lymphoma.


Condition Intervention Phase
Mantle Cell Lymphoma
Lymphoma, Mantle-Cell
Drug: Lenalidomide
Drug: Investigators choice single agent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized Open-Label Study to Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    The time from randomization to the first observation of disease progression or death due to any cause.


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    Rates for complete response (CR), complete response unconfirmed (CRu) and partial response (PR)

  • Duration of response [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    The time from initial response until disease progression or death

  • Tumor control rate [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    Rates for CR, CRu, PR and stable disease (SD)

  • Time to progression [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    Time from randomization until objective tumor progression

  • Time to treatment failure [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    From the first dose of study drug to discontinuation of treatment

  • Time to tumor response [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    Time from randomization until CR, CRu or PR

  • Overall survival [ Time Frame: Every 90 days; Ongoing ] [ Designated as safety issue: No ]
    Time from randomization until death from any cause

  • Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
    An Adverse Event is any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a patient during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology; a Serious AE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity (a substantial disruption of the patient's ability to conduct normal life functions), is a congenital anomaly/birth defect, constitutes an important medical event.

  • Quality of Life [ Time Frame: Baseline, Cycles 2, 4, 6, 8 and treatment discontinuation ] [ Designated as safety issue: No ]
    The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) is a 30-item scale composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life (QoL) scale, and six single items.


Enrollment: 254
Study Start Date: April 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide
Lenalidomide
Drug: Lenalidomide

For patients with a creatinine clearance of ≥60 mL/min: 25mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.

For patients who have a moderate renal insufficiency (creatinine clearance is ≥30 mL/min but <60mL/min: 10mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.

Other Names:
  • Revlimid
  • Rev
  • CC-5013
Active Comparator: Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, Fludarabine
Drug: Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
Other Names:
  • Leukeran
  • Ritux
  • Rituxan
  • cytosine arabinoside
  • Ara-C
  • Cytosar-U
  • Gemzar
  • fludarabine phosphate
  • Fludara

Detailed Description:

This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Currently, there is no clearly recommended standard treatment in this population. Chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. Thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma.

The present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. Enrollment goal was met on March 7th 2013 and thus enrollment was stopped.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)<1,500 cells/mm^3 (1.5 x 10^9/L)
  • Platelet count < 60,000/mm^3 (60 x 10^9/L)
  • Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or Alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) >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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875667

  Show 100 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Marek Trneny, MD/PhD/Prof Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00875667     History of Changes
Other Study ID Numbers: CC-5013-MCL-002
Study First Received: April 1, 2009
Last Updated: June 16, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Celgene Corporation:
Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Lymphoma
MCL

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Fludarabine phosphate
Fludarabine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014