Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients

Phase 2

Terminated

• Conditions: Peripheral T-cell Lymphoma
• Interventions: Drug: Lenalidomide

• Registration Number: NCT01036399
• Lead Sponsor: University of Bologna

Brief Summary

Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-07-07
• Primary Completion: 2009-08
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Study Completion: 2011-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients with histologic diagnosis of PTCL according to the WHO-REAL classification;
• Age > 18 years;
• Relapsed (³1) or refractory to conventional chemotherapy/radiotherapy;
• Stage I-IV according to the Ann Arbor staging System;
• Performance status <2;
• Adequate bone marrow reserve: platelets >50 x 10(9)/L, absolute neutrophil count
• (ANC) > 1.0 x 10(9)/L, hemoglobin >8 g/d;
• Normal renal and hepatic functions;
• Negative HIV, HCV, and HBV status;
• Informed consent prior to registration on study

Exclusion Criteria

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type A, B or C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revlimid	Lenalidomide	Oral Revlimid is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. After this induction phase, the CR, PR and SD will continue Revlimid with the same schedule for other 8 months.

Primary Outcome Measures

Name	Time	Method
To assess the feasibility of Revlimid as salvage treatment in PTCL	12 months

Secondary Outcome Measures

Name	Time	Method
To assess the overall response rate (CR and PR) of PTCL receiving REVLIMID; To assess the Tumor Control Rate (TCR); To assess the duration of response; To assess the quality of life.	12 months

Trial Locations

Locations (1)

Institute Of Hematology "Seràgnoli"; 🇮🇹 Bologna, Italy