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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(The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))
Sponsor:
Information provided by (Responsible Party):
Pier Luigi Zinzani, University of Bologna
ClinicalTrials.gov Identifier:
NCT01036399
First received: July 7, 2009
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036399

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

No publications provided by University of Bologna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pier Luigi Zinzani, Professor, University of Bologna
ClinicalTrials.gov 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:
PTCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013