Clinical trial · Observational
Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
NCT04109872CI-TRIAL-00043136unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicentric, observational and retrospective study of the use of lenalidomide in patients with relapsed or refractory mantle cell lymphoma that are included in the RRMCL spanish program. The lenalidomide effectiveness and tolerability data will be retrospectely collected until the 30 of April 2018.
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 |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Mantle cell lymphoma treated with lenalidomide cohort
- description
- Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Experience of real clinal practice lenalidomide use.
- timeFrame
- Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
- description
- Results of the the usage in real clinical practice of the lenalidomide monotherapy or combination treatment in patients with relapsed or refractory mantle cell lymphoma that aren´t candidate to other alternative treatments inside the RRMCL spanish program.
Secondary outcomes (5)
- measure
- Proportion of patients that achieve objective response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years old. * Diagnosed with relapsed or refractory mantle cell lymphoma verified by a tissue biopsy. * Treated with monotherapy or combination of lenalidomide. * Not candidate for any of the therapeutic options approved until that date for this disease. * Not candidate or unable to be included in any clinical trial due to availability or geographical difficulty. * Registered in the RRMCL spanish program. Exclusion Criteria: * ECOG \> 2. * Patients with uncontrolled comorbidities. * Blastoid variant. * Central nervous system tumor infiltration. * HIV, HBV and/or HCV active infection. * Radiotherapy concomitant treatment or that have received radiotherapy in the previous 30 days to the beginning of the first cycle of lenalidomide. * Diagnosed with other active solid tumor except for basal cell carcinoma skin cancer. * Patients that haven´t completed at least one complete cycle of the treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.