Lenalidomide in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma Leg-type : Multice… (NCT01556035) | Clinical Trial Compass
CompletedPhase 2
Lenalidomide in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma Leg-type : Multicentre Prospective Phase II Single Arm Trial of the French Study Group of Cutaneous Lymphoma
France19 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy-proven Primary cutaneous large B-cell lymphoma leg-type
* Clinically measurable skin involvement (T1-T3) or skin and nodal (N1-N3) involvement measurable by PET-CT, corresponding to :
Relapse after initial complete response (CR) after R-polychemotherapy Or Partial response or stable disease after R-polychemotherapy
* Age \> 18 years
* Life expectancy \> 3 months
* WHO performance status 0-2
* Skin biopsy performed at the inclusion on a skin tumor : new tumor in case of relapsing PCLBCL-LT or initial skin tumor refractory to the previous treatment
* Signed informed consent for clinical and biological analyses. The Lenalidomide Information Sheet will be given to each patient receiving lenalidomide study therapy. The patient must read this document prior to starting lenalidomide study treatment and each time they receive a new supply of study drug.
* Social security cover
* Conditions of global RPP have to be fulfilled by all the patients
* The Lenalidomide Education and Counseling Guidance Document must be completed and signed by either a trained counselor or the Investigator at the participating clinical center prior to each dispensing of lenalidomide study treatment. A copy of this document must be maintained in the patient records.
Exclusion Criteria:
* Central nervous system involvement (cerebral CT scan is performed at the inclusion)
* One or more of the biological abnormalities :
Neutrophil count \< 1,500/mm3 ; Platelet count \< 60,000/m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested lenalidomide specifically in primary cutaneous large B-cell lymphoma, leg-type — has this trial's data been published, and what did the overall response rate at 6 months turn out to be, so we can understand how well it worked for people in my situation?
2Since this was a Phase 2 trial, meaning it was still building evidence on safety and effectiveness, how confident are doctors now in lenalidomide as a treatment option for relapsed or refractory PCLBCL leg-type compared to other available options?
3My lymphoma is relapsed or refractory, which means it came back or stopped responding to treatment — based on what this trial found, would lenalidomide be a realistic next step for me, or are there other approaches my care team would consider first?
4Lenalidomide is an immunomodulating drug with known side effects like blood clots and low blood counts — given my overall health and history, how would my doctor weigh those risks against the potential benefit suggested by this trial?
5Since this trial has already completed, is there any follow-up data or newer research building on these results that might give us a clearer picture of whether lenalidomide leads to lasting remissions in this type of lymphoma?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate (complete response CR and partial response PR) at 6 months