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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109872
• Other study ID #: FIS-LEN-2018-01
• Status: Recruiting
• Start date: September 15, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: September 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Carlos García Pérez
• Phone: 955 00 80 00
• Email: administracion.eecc.hvm.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 15, 2020
• Est. primary completion date: June 15, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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