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Phase 2
18 Years
Not Enrolling
Peripheral T-cell Lymphoma

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Trial Information

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.

Type of Study:


Study Design:

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

Outcome Measure:

To assess the feasibility of Revlimid as salvage treatment in PTCL

Outcome Time Frame:

12 months

Safety Issue:



Italy: Ethics Committee

Study ID:




Start Date:

November 2008

Completion Date:

August 2011

Related Keywords:

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