An observational study in Mantle Cell Lymphoma, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 25 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla