Lenalidomide Maintenance Post-debulking in Advanced CTCL

Phase 3

Terminated

• Conditions: Lymphoma
• Interventions: Drug: lenalidomide

• Registration Number: NCT01098656
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-02
• Study First Posted: 2010-04-05
• Study Start: 2010-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lenalidomide	lenalidomide	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival as assessed by hematogenous disease criteria
Conversion rate
Rate of occurrence of second cancers at any site
Acute and late toxicity
Overall survival

Trial Locations

Locations (22)

Medical University of Graz; 🇦🇹 Graz, Austria

Medical University Vienna - General Hospital; 🇦🇹 Vienna, Austria

Cliniques Universitaires St. Luc; 🇧🇪 Brussels, Belgium

Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet; 🇧🇪 Brussels, Belgium

U.Z. Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Helsinky University Central Hospital - Skin & Allergy Hospital; 🇫🇮 Helsinki, Finland

Nouvel Hopital Estaing; 🇫🇷 Clermont-Ferrand, Cedex 1, France

Chu de Bordeaux - Hopital Du Haut Leveque; 🇫🇷 Bordeaux, Pessac Cedex, France

Chu Lyon - Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, Pierre-Benite Cedex, France

Chu Amiens - Hopital Sud; 🇫🇷 Amiens, France

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