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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mantle cell lymphoma treated with lenalidomide cohort | Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos García Pérez | Contact | 955 00 80 00 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Carlos García Pérez | Hospital Universitario Virgen Macarena | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| 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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |