Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.

• Conditions: Mantle Cell Lymphoma
• Interventions: Drug: Lenalidomide

• Registration Number: NCT04109872
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-15
• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-06-15
• Study Completion: 2020-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mantle cell lymphoma treated with lenalidomide cohort	Lenalidomide	Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.

Primary Outcome Measures

Name	Time	Method
Experience of real clinal practice lenalidomide use.	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	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 Outcome Measures

Name	Time	Method
Proportion of patients that achieve objective response.	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	The objective response will be measured in terms of complete response, not confirmed complete response and partial response according to the 2007 International Working Group criteria after the 6º treatment cycle.
Verify the disease overall survival.	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	The disease overall survival is defined as the time that passes from the inclusion in the record until a control is done or the patient´s death.
Verify the disease free survival.	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	The disease free survival is defined as the time that passes from the inclusion in the record until a control is done or takes place a relapse (local or distant).
Evaluate the incidence of treatment adverse events.	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	Number and description of adverse effects due to the lenalidomide treatment.
Duration of the response.	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	Partial and complete response duration.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain