Clinical trial NCT01036399: Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral T-cell Lymphoma
Keywords: PTCL
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To assess the feasibility of Revlimid as salvage treatment in PTCL
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Institute Of Hematology "Seràgnoli"
Study officials:
References:
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.