Lenalidomide Maintenance Post-debulking in Advanced CTCL

July 6, 2018 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz
      • Vienna, Austria, 1090
        • Medical University Vienna - General Hospital
  • Belgium
      • Brussels, Belgium
        • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Brussels, Belgium
        • Cliniques Universitaires St. Luc
      • Leuven, Belgium
        • U.Z. Leuven - Campus Gasthuisberg
  • Finland
      • Helsinki, Finland, 00029
        • Helsinky University Central Hospital - Skin & Allergy Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Paris, France, 75475
        • Hopital Saint-Louis
      • Reims, France, 51092
        • CHU de Reims - Hôpital Robert Debré
    • Cedex 1
      • Clermont-Ferrand, Cedex 1, France, 66003
        • Nouvel Hopital Estaing
    • Pessac Cedex
      • Bordeaux, Pessac Cedex, France, 33604
        • CHU de Bordeaux - Hôpital du Haut Lévèque
    • Pierre-Benite Cedex
      • Lyon, Pierre-Benite Cedex, France, 69495
        • CHU Lyon - Centre Hospitalier Lyon Sud
  • Germany
      • Berlin, Germany
        • Charite - Universitaetsmedizin Berlin - Campus Mitte
      • Mainz, Germany
        • Johannes Gutenberg Universitaetskliniken
      • Minden, Germany
        • Johannes Wesling Klinikum Minden
  • Spain
      • L'Hospitalet De Llobregat, Spain, 08907
        • Csu de Bellvitge (Institut Catala D'Oncologia)
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
  • Switzerland
      • Zurich, Switzerland
        • UniversitaetsSpital Zurich - Division of Oncology
  • United Kingdom
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS - St Thomas Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust - City Hospital campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnoses of advanced T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome

    • Stage IIB-IV disease

  • Achieved complete or partial response after undergoing prior debulking therapy with 1 of the following recommended* regimens with or without radiotherapy**:

    • Gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 of a 28-day course at a dose of 1,000 to 1,200 mg/m² for a total of four courses
    • Pegylated liposomal doxorubicin hydrochloride IV over 1 hour on days 1 and 15 of a 28-day course at a dose of 20 mg/m² for a total of four courses NOTE: *These recommended regimens can be altered according to local institutional policies. In case of drug intolerance, the study regimen can be switched from one regimen to the other.

NOTE: **Local low-dose/energy-ionizing radiation therapy allowed as part of the debulking process to treat lesions that do not respond after 3 courses of debulking chemotherapy.

  • Sézary cell burden must be decreased by at least 50% after debulking in patients with Sézary syndrome
  • Disease not appropriate for skin-directed therapy per local institution standards
  • No disease progression between registration and randomization
  • No CNS involvement

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Life expectancy > 12 months
  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 60 x 10^9/L
  • Total bilirubin ≤ 1.5 times upper limit of normal (UNL)
  • Alkaline phosphatase ≤ 3 times UNL
  • ALT/AST ≤ 3 times UNL
  • Electrolytes (including sodium, potassium, and chloride) normal
  • Creatinine normal
  • Creatinine clearance ≥ 60 mL/min
  • Uric acid and calcium normal
  • Free T4 and TSH ≤ 1.5 times ULN
  • Patients with a buffer range from the normal values of +/- 10% for hematology and biochemistry are acceptable
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception 4 weeks prior to, during, and for 4 weeks after completion of study therapy
  • Males must agree not to donate semen during and for 1 week after completion of study therapy
  • Patients with high risk for or history of a thromboembolic event must agree to receive prophylactic anticoagulation therapy (e.g., vitamin K) to keep INR in the range of 2-3
  • No New York Heart Association class III-IV disease
  • No blood donating during and for 1 week after completion of study therapy
  • No uncontrolled infectious disease, autoimmune disease, or immunodeficiency
  • No second malignancies within the past 3 years except surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal or squamous cell carcinoma of the skin
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • No Lapp lactase deficiency or history of glucose-galactose malabsorption

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No other prior intravenous chemotherapy for this cancer

    • For purposes of this protocol, the definition of intravenous chemotherapy also includes denileukin diftitox, antibodies, or antibody conjugates
  • No prior splenectomy or splenic irradiation

  • No concurrent topical corticosteroids

    • Concurrent systemic corticosteroids allowed for treatment of tumor flare reactions
  • No radiation or drug-based therapy (including steroids) between registration and randomization

  • No other concurrent drugs (including steroids) during the debulking regimen

    • Low-dose steroids as premedication allowed at the investigator's discretion
  • No other concurrent anticancer treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Observation
Experimental: lenalidomide
Drug: lenalidomide

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Progression-free survival

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Martine Bagot, MD, Hopital Saint-Louis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EORTC-21081
  • EU-21020
  • 2009-011020-65 (EudraCT Number)
  • CELGENE-EORTC-21081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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