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

Peripheral T-cell Lymphoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01036399
• Other study ID #: RV-PTCL-PI-277
• Secondary ID: EUDRACT 2007-003
• Status: Terminated
• Phase: Phase 2
• First received: July 7, 2009
• Last updated: August 24, 2012
• Start date: November 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2012
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• Lenalidomide
Oral Lenalidomide 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.

Locations

Country	Name	City	State
Italy	Institute Of Hematology "Seràgnoli"	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of Revlimid as salvage treatment in PTCL		12 months	Yes
Secondary	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	Yes