Peripheral T-cell Lymphoma
Conditions
Keywords
PTCL
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.
Interventions
DRUGLenalidomide
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.
Sponsors
University of Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility of Revlimid as salvage treatment in PTCL | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 12 months |
Countries
Italy
Outcome results
None listed