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 AGGRESSIVE NON-HODGKIN’S LYMPHOMA

• Conditions: Relapsed or refractory aggressive non-Hodgkin's lymphoma; MedDRA version: 8.1Level: PTClassification code 10029610Term: Non-Hodgkin's lymphoma unspecified histology aggressive refractory

• Registration Number: EUCTR2006-004500-40-DE
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

•Signed informed consent.
•= 18 years of age at the time of signed informed consent.
•Able to adhere to the study visit schedule and other protocol requirements.
•Biopsy-proven aggressive non-Hodgkin’s lymphoma.
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
•Relapsed or refractory to previous therapy for lymphoma.
•Subjects must have received at least 1 prior combination chemotherapy regimen. There is no limit on the number of prior therapies.
•Subjects who have relapsed following an autologous stem cell transplant are eligible.
•Subjects must have measurable disease on cross sectional imaging 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 (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The 2 methods of reliable contraception must include 1 highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.

Before starting study drug:

Female Subjects:
- FCBP must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
- Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.
- Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study.

Male Subjects:
- Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
- Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure.
- Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study.

During study participation and for 28 days following discontinuation from the study:
All Subjects:
- No more than a 28-day supply of study drug will be dispensed at a time.

Female Subjects:
- FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study disconti

Exclusion Criteria

•Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 10e9/L).
- Platelet count < 60,000/mm3 (60 x 10e9/L).
- Calculated creatinine clearance (Cockcroft-Gault formula) of 50 ml/min.
- Serum SGOT/AST or SGPT/ALT 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.
•Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
•Subjects who are post allogenic stem cell transplant
•All subjects with central nervous system (CNS) lymphoma. Subjects with previous CNS lymphoma that have been treated with chemotherapy, radiotherapy or surgery, who have remained asymptomatic, for 90 days (3 months) and demonstrate no CNS lymphoma, as showm by lumbar puncture, CT scan or MRI are eligible. (If required, lumbar puncture, CT or MRI should be performed during screening process.) Subjects should not be receiving corticosteroids.
•Prior history of malignancies other than NHL (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 = 365 days (1 year).
•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Known positive for HIV.
•Pregnant or lactating females.
•Ejection fraction not within normal institutional limits.
•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 168 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.
•Known active Hepatitis B or C.

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 aggressive non-Hodgkin’s lymphoma. 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 aggressive NHL.;Primary end point(s): •Response rate (Complete Response + Complete Response unconfirmed + Partial Response)