Lenalidomide Maintenance Post-debulking in Advanced CTCL

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Terminated

Phase 3

Conditions

Lymphoma

Treatments

Drug: lenalidomide

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01098656

EU-21020

EORTC-21081

2009-011020-65 (EudraCT Number)

CELGENE-EORTC-21081

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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