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

Primary Purpose

Peripheral T-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring PTCL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute Of Hematology "Seràgnoli"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Revlimid

Arm 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.

Outcomes

Primary Outcome Measures

To assess the feasibility of Revlimid as salvage treatment in PTCL

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.

Full Information

First Posted
July 7, 2009
Last Updated
August 24, 2012
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01036399
Brief Title
Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene)
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
PTCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Revlimid
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the feasibility of Revlimid as salvage treatment in PTCL
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institute Of Hematology "Seràgnoli"
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21504290
Citation
Zinzani PL, Pellegrini C, Broccoli A, Stefoni V, Gandolfi L, Quirini F, Argnani L, Berti E, Derenzini E, Pileri S, Baccarani M. Lenalidomide monotherapy for relapsed/refractory peripheral T-cell lymphoma not otherwise specified. Leuk Lymphoma. 2011 Aug;52(8):1585-8. doi: 10.3109/10428194.2011.573031. Epub 2011 Apr 19. No abstract available.
Results Reference
derived

Learn more about this trial

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

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