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

NCT04109872 | Unknown

• 1 other identifier: FIS-LEN-2018-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Mantle Cell Lymphoma

Keywords

Lenalidomide; Mantle Cell Lymphoma; Relapsed; Refractory; RRMCL spanish program

Outcome Measures

Primary Outcomes (1)

• Experience of real clinal practice lenalidomide use.

  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.

  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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Mantle cell lymphoma treated with lenalidomide cohort

Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.

Mantle cell lymphoma treated with lenalidomide cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with mantle cell lymphoma that received lenalidomide through the RRMCL program as long as they meet all the inclusion criteria and none of the exclusion and independently from being dead or alive in the moment of data record.

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Recurrence

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Carlos García Pérez

  Hospital Universitario Virgen Macarena

  STUDY CHAIR

Central Study Contacts

Carlos García Pérez

CONTACT

955 00 80 00; administracion.eecc.hvm.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: September 15, 2018
• Primary Completion: June 15, 2020
• Study Completion: July 15, 2020
• Last Updated: February 5, 2020

Record last verified: 2019-09

Locations

ES (1)