A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY T-CELL NON-HODGKIN’S LYMPHOMA - The EXPECT Trial
- Conditions
- •Relapsed or refractory T-cell non Hodgkin's lymphomaMedDRA version: 9.1Level: HLGTClassification code 10018865Term: Haematopoietic neoplasms (excl leukaemias and lymphomas)
- Registration Number
- EUCTR2007-002171-13-BE
- Lead Sponsor
- Celgene International Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
•Must understand and voluntarily sign an informed consent form.
•Must be = 18 years of age at the time of signing the informed consent form.
•Must be able to adhere to the study visit schedule and other protocol requirements.
•Biopsy-proven T-cell non-Hodgkin’s lymphoma, either:
- Peripheral T-Cell Lymphoma (PTCL) whatever the subtype, or
- Cutaneous T-Cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
•Relapsed or refractory to previous therapy for T-cell NHL.
•Must have received at least one prior combination chemotherapy containing at least two cytotoxic agents. There is no limit on the number of prior therapies.
•Subjects who have relapsed following an autologous stem cell transplant are eligible.
•Must have measurable disease on cross sectional imaging (CT or MRI) that is at least 2 cm in the longest diameter.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
•Life expectancy of = 90 days (3 months).
•Females of childbearing potential (FBCP) must
- Have two negative medically supervised pregnancy test prior to starting of study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices complete and continued sexual abstinence.
- Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without any interruption, 28 days prior to starting study drug, during the study treatment (including dose interruptions), and for 28 days after discontinuation of study treatment.
•Males subjects must:
-Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug treatment, during any dose intereeuption and after cessation of study treatment
- Agree not to donate semen during study drug treatment and for a period after end of study drug treatment
-•All subjects must:
-Have an understanding that the study drug could have a potential teratogenic risk
-Agree to abstain from donating blood while taking study drug treatment and following discontinuation of study drug treatment
-Agree not to share study drug with another person
-Be counseled about pregnancy precautions and risks of fetal exposure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•CTCL of subtype Sézary syndrome; i.e. subjects with >5% Sezary cells (Wilson LD, et al, 2001).
•Any of the following laboratory abnormalities.
-Absolute neutrophil count (ANC) < 1,500 cells/mm3(1.5 x 10 9/L).
-Platelet count < 60,000/mm3 (60 x 10 9/L).
-Serum asparate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 5.0 x upper limit of normal (ULN).
-Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL, except in case of hemolytic anemia.
•Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min.
•Candidates for and willing to undergo an autologous stem cell transplant.
•Subjects who are post allogenic stem cell transplant.
•Active CNS lymphoma with the exception of those subjects whose CNS lymphoma has been treated with chemotherapy, radiotherapy or surgery, have remained asymptomatic for 90 days (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT or MRI are eligible. If required, lumbar puncture, CT or MRI should be performed during the screening process. Subjects should not be receiving corticosteroids.
•Prior history of malignancies other than T-cell lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for = 2 years.
•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Known positive for Human Immunodeficiency Virus (HIV).
•Pregnant or lactating females.
•Uncontrolled intercurrent illness including, but not limited to:
-Ongoing or active infection requiring parenteral antibiotics.
-Uncontrolled diabetes mellitus as defined by the investigator.
-Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease).
-Unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 180 days (6 months).
-Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
•Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide.
•Prior = Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
•Subjects with = Grade 2 neuropathy.
•Prior use of lenalidomide.
•Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy. Once on study, symptomatic tumor flare reaction may be treated with prednisone (or equivalent) as necessary
•Use of steroids as part of anti-lymphoma treatment. However physiologic doses of steroids (= 10 mg/day) for other indications will be allowed. Once on study, symptomatic tumor flare reaction may be treated with prednisone (or equivalent) as necessary.
•Known active Hepatitis B or C.
• Recent (within the past 30 days) onset of hemolytic anemia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell NHL. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.;Secondary Objective: •To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.;Primary end point(s): •Response rate
- Secondary Outcome Measures
Name Time Method