Mantle Cell LymphomaNCT04109872
Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
An observational study of Mantle Cell Lymphoma, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Lenalidomide
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2018to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Carlos García Pérez, 955 00 80 00, administracion.eecc.hvm.sspa@juntadeandalucia.es
About this study
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
- Being tested
- Lenalidomide
- Keywords
- Lenalidomide, Mantle Cell Lymphoma, Relapsed, Refractory, RRMCL spanish program
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.
| Study group | Role | What they receive |
|---|---|---|
| Mantle cell lymphoma treated with lenalidomide cohort | Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Sep 2018
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos García Pérez, Study chair, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109872
- Sponsor's protocol ID
- FIS-LEN-2018-01
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
- ClinicalTrials.gov ID
- NCT04109872
- Acronym / sponsor ID
- FIS-LEN-2018-01
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Lenalidomide, Mantle Cell Lymphoma, Relapsed, Refractory, RRMCL spanish program
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mantle cell lymphoma treated with lenalidomide cohort | – | Drug: LenalidomidePatients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (8 listed)
- ECOG > 2.
- Patients with uncontrolled comorbidities.
- Blastoid variant.
- Central nervous system tumor infiltration.
- HIV, HBV and/or HCV active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideLenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018. | Drug | Mantle cell lymphoma treated with lenalidomide cohort |
Primary outcome
Experience of real clinal practice lenalidomide use.
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
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.
5 secondary outcomes
Proportion of patients that achieve objective response.
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.
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.
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos García Pérez study chair
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos García Pérez (955 00 80 00, administracion.eecc.hvm.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of real clinal practice lenalidomide use. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.