A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (Sprint)
|Mantle Cell Lymphoma Lymphoma, Mantle-Cell||Drug: Lenalidomide Drug: Investigators choice single agent||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
- Progression free survival (PFS) [ Time Frame: Every 90 days; Up to 95 months ]The time from randomization to the first observation of disease progression or death due to any cause.
- Overall response rate [ Time Frame: Every 90 days; Up to 95 months ]Rates for complete response (CR), complete response unconfirmed (CRu) and partial response (PR)
- Duration of response [ Time Frame: Every 90 days; Up to 95 months ]The time from initial response until disease progression or death
- Tumor control rate [ Time Frame: Every 90 days; Up to 95 months ]Rates for CR, CRu, PR and stable disease (SD)
- Time to progression [ Time Frame: Every 90 days; Up to 95 months ]Time from randomization until objective tumor progression
- Time to treatment failure [ Time Frame: Every 90 days; Up to 95 months ]From the first dose of study drug to discontinuation of treatment
- Time to tumor response [ Time Frame: Every 90 days; Up to 95 months ]Time from randomization until CR, CRu or PR
- Overall survival [ Time Frame: Every 90 days; Up to 95 months ]Time from randomization until death from any cause
- Safety [ Time Frame: Up to 95 months ]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; Up to 95 months ]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.
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||December 7, 2017|
|Estimated Primary Completion Date:||December 7, 2017 (Final data collection date for primary outcome measure)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875667
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|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|