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

University of Bologna

Status and phase: Terminated; Phase 2

Conditions: Peripheral T-cell Lymphoma

Treatments: Drug: Lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT01036399

EUDRACT 2007-003911-29

RV-PTCL-PI-277

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Revlimid

Experimental group

Description:

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.

Treatment:

Drug: Lenalidomide