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

This study has been terminated.
(The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))
Information provided by (Responsible Party):
Pier Luigi Zinzani, University of Bologna Identifier:
First received: July 7, 2009
Last updated: August 24, 2012
Last verified: August 2012
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.

Condition Intervention Phase
Peripheral T-cell Lymphoma
Drug: Lenalidomide
Phase 2

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

Resource links provided by NLM:

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • To assess the feasibility of Revlimid as salvage treatment in PTCL [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Revlimid

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.

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.
Other Name: Revlimid


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01036399

Institute Of Hematology "Seràgnoli"
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pier Luigi Zinzani, Professor, University of Bologna Identifier: NCT01036399     History of Changes
Other Study ID Numbers: RV-PTCL-PI-277  EUDRACT 2007-003911-29 
Study First Received: July 7, 2009
Last Updated: August 24, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016