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(The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene))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
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.
Peripheral T-cell Lymphoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2009 (Final data collection date for primary outcome measure)
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.
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:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036399
|Institute Of Hematology "Seràgnoli"
|Bologna, Italy, 40138 |
University of Bologna
No publications provided by University of Bologna
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Epub 2011 Apr 19. No abstract available.
||Pier Luigi Zinzani, Professor, University of Bologna
History of Changes
|Other Study ID Numbers:
||RV-PTCL-PI-277, EUDRACT 2007-003911-29
|Study First Received:
||July 7, 2009
||August 24, 2012
||Italy: Ethics Committee
Keywords provided by University of Bologna:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Immune System Diseases