Phase II Single Agent Lenalidomide (Revlimid) in Relapsed / Refratory Mantle Cell Lymphoma. - Lenalidomide Study

Phase 1

Active, not recruiting

• Conditions: Relapsed / Refractory Mantle Cell Lymphoma; MedDRA version: 14.1Level: PTClassification code 10026800Term: Mantle cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-005472-13-GB
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-02
• Study Completion: 2016-12-16
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Male and female patients 18 years and older
A confirmed mantle cell lymphoma which is refractory to, or relapsed following the completion of 2 or more anti-neoplastic therapies - All chemotherapy regimens are permissible
Measrable disease
Karnofsky Performance Status >/= 50% (ECOG 0-2)
Absolute neutrophil count of >/= 1000 cells/uL, not related to lymphoma
Platelets >/= 30,000 cells/uL
Aspartate transaminase Toxic effects of previous therapy or surgery resolved to grade 2 or better
Female patients who are either post-menopausal, sugically sterilised or willing to use 2 acceptable methods of birth control
Male patients who agree to use an acceptable method of birth control for the duration of the study
Patients who have given written informed consent, prior to any study related proceedures
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

Exclusion Criteria

Patients known to be serologically positive for HBV, HCV or HIV
Previous treatment with lenalidomide
Any anti-neoplastic therapy within 3 weeks prior to Day 1 of Cycle 1
Any nitrosoureas within 6 weeks prior to Day 1 of Cycle 1
Treatment with Rituximab, Alemtuzumab or other unconjugated therapeutic antibody within 4 weeks prior to Day 1 of Cycle 1
Radiation therapy within 3 weeks before Day 1 of Cycle 1
Major surgery within 2 weeks prior to Day 1 of Cycle 1
Active systemic infection requiring treatment
Any concurrent active malignancy
female patients who may be pregnant or breast-feeding
Serious medical or psychiatric illness likely to interfere with participation in this study
Concurrent treatment with another investigational agent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the rates of overall response to lenalidomide in terms of complete response, complete response unconfirmed and partial response;Secondary Objective: To evaluate the duration of response<br>To determine the median time to progression<br>To determine the median overall survival<br>To evaluate the toxicity and tolerability of the research treatment;Primary end point(s): Disease progression<br>Unacceptable toxicity or tolerability<br>Patients withdarawl of consent