Diffuse Large B Cell LymphomaRE-MINDNCT04150328
Lenalidomide Monotherapy in R/R DLBCL
An observational study of Diffuse Large B Cell Lymphoma, run by MorphoSys AG at 57 sites in 4 countries.
Trial summary
This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- How many people
- 490 participants
- Where
- 57 sitesin 4 countries
- Study dates
- 12 Apr 2019to 25 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy
Who may be able to join
- Histologically confirmed diagnosis of DLBCL
- Relapsed/refractory to at least one previous systemic therapy for DLBCL
- Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
- Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT
Who cannot join
- CNS involvement by lymphoma
- Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
- Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
- Patients who previously underwent allogeneic SCT
- Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
- Patients with a history of other malignancies within 5 years prior to lenalidomide treatment start
Trial locations and contacts
57 sites in 4 countries.
57 sites in 4 countries
Italy35 sites
MorphoSys Research Site
Aviano, 33081
MorphoSys Research Site
Bergamo, 24127
MorphoSys Research Site
Bologna, 40138
MorphoSys Research Site
Brescia, 25123
MorphoSys Research Site
Como, 22100
MorphoSys Research Site
Cuneo, 12100
MorphoSys Research Site
Florence, 50134
MorphoSys Research Site
Meldola, 47014
MorphoSys Research Site
Milan, 20132
MorphoSys Research Site
Milan, 20141
MorphoSys Research Site
Milan, 20162
MorphoSys Research Site
Modena, 41124
MorphoSys Research Site
Naples, 80131_2
MorphoSys Research Site
Naples, 80131
MorphoSys Research State
Novara, 28100
MorphoSys Research Site
Padova, 35128
MorphoSys Research Site
Parma, 43126
MorphoSys Research Site
Pavia, 27100
MorphoSys Research Site
Perugia, 06129
MorphoSys Research Site
Piacenza, 29121
MorphoSys Research Site
Ponderano, 13875
MorphoSys Research Site
Ravenna, 48121
MorphoSys Research Site
Reggio Emilia, 42132
MorphoSys Research Site
Rimini, 47923
MorphoSys Research Site
Roma, 00128
MorphoSys Research Site
Roma, 00161
MorphoSys Research Site
Roma, 00189
MorphoSys Research Site
Salerno, 84131
MorphoSys Research Site
San Giovanni Rotondo, 71013
MorphoSys Research Site
Torino, 10126_2
MorphoSys Research Site
Torino, 10126
MorphoSys Research Site
Torino, 10128
MorphoSys Research Site
Udine, 33100
MorphoSys Research Site
Verona, 37100
MorphoSys Research Site
Vicenza, 36100
France11 sites
MorphoSys Research Site
Bordeaux, 76038
MorphoSys Research Site
Le Mans, 72037
MorphoSys Research Site
Lille, 59037
MorphoSys Research Site
Lyon, 69495
MorphoSys Research Site
Paris, 75010
MorphoSys Research Site
Paris, 75743
MorphoSys Research Site
Poitiers, 86000
MorphoSys Research Site
Pontoise, 95300
MorphoSys Research Site
Rouen, 76038
MorphoSys Research Site
Toulouse, 31059
MorphoSys Research Site
Tours, 37044
United States8 sites
MorphoSys Research Site
Charleston, South Carolina, 29425
MorphoSys Research Site
Dublin, Ohio, 43017
MorphoSys Research Site
Greenville, South Carolina, 29615
MorphoSys Research Site
Manhasset, New York, 11030
MorphoSys Research Site
New York, New York, 10013
MorphoSys Research Site
Rochester, Minnesota, 55905
MorphoSys Research Site
Rochester, New York, 14642
MorphoSys Research Site
St Louis, Missouri, 63110
Spain3 sites
MorphoSys Research Site
Barcelona, 08003
MorphoSys Research Site
Madrid, 28041
MorphoSys Research Site
Salamanca, 37007
About this study
Official title: An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)
This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)
Read the detailed description
Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.
- Conditions
- Diffuse Large B Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall/objective response rate (ORR)
Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study
Measured: Through study completion, an average of 9 months
Secondary outcomes (3)
Overall survival
Time from treatment start until death from any cause
Measured: Through study completion, an average of 9 months
Complete response rate
Proportion of patients having CR based on the best objective response achieved at any time during the study
Measured: Through study completion, an average of 9 months
Disease control rate
Proportion of patients having CR, PR or stable disease (SD) based on the best objective response achieved at any time during the study
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start12 Apr 2019
- Primary completion25 Aug 2019
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- MorphoSys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150328
- Sponsor's protocol ID
- MOR208C206
- Acronym
- RE-MIND
- Status last verified
- Aug 2022
- First submitted
- 31 Oct 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)
- ClinicalTrials.gov ID
- NCT04150328
- Acronym / sponsor ID
- RE-MIND / MOR208C206
- Conditions
- Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- MorphoSys AGIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 4 Nov 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 observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)
Detailed description
Tafasitamab (MOR00208) is currently in development for the treatment of R/R DLBCL. An ongoing, single-arm, phase II, open label, multicenter study (MOR208C203) is evaluating the efficacy and safety of tafasitamab combined with lenalidomide in patients with R/R DLBCL. In order to establish a lenalidomide monotherapy as a control cohort, this observational study aims to collect retrospective lenalidomide monotherapy data from real-world-evidence and to compare it with the tafasitamab-lenalidomide combination therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- R/R DLBCL patients not eligible for HDC followed by ASCT who were treated with lenalidomide monotherapy
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of DLBCL
- Relapsed/refractory to at least one previous systemic therapy for DLBCL
- Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL, including at least one anti-CD20 containing therapy
- Received lenalidomide monotherapy for R/R DLBCL while being considered not eligible for an ASCT
Key exclusion criteria (6 listed)
- CNS involvement by lymphoma
- Patients who received lenalidomide in combination with another anti-lymphoma therapy (including radiation)
- Previously treated with anti-CD19-targeted therapy or immunomodulatory drugs
- Patients who previously underwent allogeneic SCT
- Known simultaneous detection of MYC and BCL2 or BCL6 translocation according to FISH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best overall/objective response rate (ORR)
Time frame: Through study completion, an average of 9 months
Proportion of patients with complete response (CR) or partial response (PR) as best response achieved at any time during the study
3 secondary outcomes
Overall survival
Time frame: Through study completion, an average of 9 months
Complete response rate
Time frame: Through study completion, an average of 9 months
Disease control rate
Time frame: Through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma, run by MorphoSys AG at 57 sites in 4 countries.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Italy, France, United States, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best overall/objective response rate (ORR) (time frame: Through study completion, an average of 9 months). 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 24 Aug 2022.