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Lenalidomide Maintenance Post-debulking in Advanced CTCL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: lenalidomide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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)


No Intervention: Observation



Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Progression-free survival as assessed by hematogenous disease criteria
  3. Acute and late toxicity
  4. Conversion rate
  5. Rate of occurrence of second cancers at any site


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Show Show 22 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Martine Bagot, MD Hopital Saint-Louis
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01098656    
Other Study ID Numbers: EORTC-21081
EU-21020
2009-011020-65 ( EudraCT Number )
CELGENE-EORTC-21081
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents