Lenalidomide Maintenance Post-debulking in Advanced CTCL
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|ClinicalTrials.gov Identifier: NCT01098656|
Recruitment Status : Terminated (recruitment prematurely halted following company's decision to stop financial support to the study)
First Posted : April 5, 2010
Last Update Posted : July 9, 2018
RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome.
PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: lenalidomide||Phase 3|
- To determine if observation versus lenalidomide maintenance therapy after debulking with gemcitabine hydrochloride or pegylated liposomal doxorubicin hydrochloride with or without radiotherapy prolongs progression-free survival of patients with advanced stage IIIB or IV T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome not previously treated with other intravenous chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to institution, response to debulking treatment (complete response vs partial response), and disease (mycosis fungoides [MF] vs erythrodermic MF/Sézary syndrome). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 4-6 weeks after completion of prior debulking therapy, patients undergo observation for 560 days.
- Arm II: Beginning 4-6 weeks after completion of prior debulking therapy, patients receive oral lenalidomide once a day on days 1-21. Treatment repeats every 28 days for 20 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
The starting dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles.
Dosing is continued or modified based upon clinical and laboratory findings (dose reductions: 20 mg, 15 mg, 10 mg and 5 mg)
|No Intervention: Observation|
- Progression-free survival
- Overall survival
- Progression-free survival as assessed by hematogenous disease criteria
- Acute and late toxicity
- Conversion rate
- Rate of occurrence of second cancers at any site
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098656
|Study Chair:||Martine Bagot, MD||Hopital Saint-Louis|