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

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ClinicalTrials.gov Identifier: NCT01036399
Recruitment Status : Terminated (The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))
First Posted : December 21, 2009
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Lenalidomide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2008
Primary Completion Date : August 2009
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. To assess the feasibility of Revlimid as salvage treatment in PTCL [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036399


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

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
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2012

Keywords provided by Pier Luigi Zinzani, 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
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents