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

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.

Study Overview

• Status: Unknown
• Conditions: Mantle Cell Lymphoma
• Intervention / Treatment: Drug: Lenalidomide

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
    • Contact: Carlos García Pérez; Phone Number: 955 00 80 00; Email: administracion.eecc.hvm.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mantle cell lymphoma treated with lenalidomide cohort; Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.	Drug: Lenalidomide; Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients that achieve objective response.	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.	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.	Partial and complete response duration.	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.	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).	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.	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.	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.	Number and description of adverse effects due to the lenalidomide treatment.	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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Study Chair: Carlos García Pérez, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2018
• Primary Completion (ANTICIPATED): June 15, 2020
• Study Completion (ANTICIPATED): July 15, 2020

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Relapsed; Refractory; Lenalidomide; Mantle Cell Lymphoma; RRMCL spanish program
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Mantle-Cell; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: FIS-LEN-2018-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No