CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Lenalidomidedrug
Likely dose
Lenalidomide 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01556035
NCT01556035Phase 2Completed

A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)

University Hospital, Bordeaux·interventional·Posted Mar 16, 2012·Updated May 14, 2026

In Brief

A Phase 2 clinical trial evaluating Lenalidomide for Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type). Completed, enrolled 19 participants across 24 sites.

Detailed Summary

In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients. If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2012
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.3 years ago

Interventions

Lenalidomidedrug

Patient orally treated with lenalidomide 25 mg daily for 21 days with 7 days rest of a 28 days cycle.Treatment maintained for 12 months unless progression