Clinical trial · Interventional
Study of Lenalidomide (Revlimid) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The EC withdrawn the approval becuase of possible conflicts of interests between our Institute and Supporter (Celgene)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Revlimid
- 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.
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- To assess the feasibility of Revlimid as salvage treatment in PTCL
- timeFrame
- 12 months
Secondary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZinzani 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. PMID 21504290