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

NCT ID: NCT01036399

Last Updated: 2012-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral T-cell Lymphoma

Keywords

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PTCL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lenalidomide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Revlimid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Pier Luigi Zinzani

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute Of Hematology "Seràgnoli"

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 21504290 (View on PubMed)

Other Identifiers

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EUDRACT 2007-003911-29

Identifier Type: -

Identifier Source: secondary_id

RV-PTCL-PI-277

Identifier Type: -

Identifier Source: org_study_id