Follicular LymphomaNCT05529524
Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)
An observational study of Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 9 sites in France.
Trial summary
Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- How many people
- 6 participants
- Where
- 9 sitesFrance
- Study dates
- 7 Nov 2022to 22 Jan 2024
- 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: patients who participate to CELESTIMO study (NCT04712097)
patients who participate to CELESTIMO study (NCT04712097)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Hospitalier de La Cote Basque; Hematologie
Bayonne, 64109
Hopital Claude Huriez; Hematologie
Lille, 59037
Institut Paoli Calmettes
Marseille, 13273
CHU Saint Eloi; Service d'Hématologie Clinique
Montpellier, 34295
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
Nantes, 44000
CHU de Nîmes - Hôpital Carémeau
Nîmes, 30029
Hopital Saint Antoine; Hematologie Clinique
Paris, 75012
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Poitiers, 86021
CHU Pontchaillou
Rennes, 35033
About this study
Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.
Read the detailed description
the objective is to produce a collection of great scientific interest for lymphoma research from CELESTIMO's clinical trial patients' samples to increase knowledge of treatment with mosunetuzumab's for patients with follicular lymphoma (FL).
study population involves patients participating to CELESTIMO study in France. 10 sites are expected in this biobanking protocol study
Biological samples will collected as part of routine care (tissue and blood already sampled in routine and/or CELESTIMO study) at screening, at C4, at C12 or at progressive disease/relapse.
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma, Mosunetuzomab, Resistance, CD20-CD3, Bispecific antibodies, Neoplasms, Lymphatic Diseases, Immunoproliferative Disorders
- Medical subject headings
- Lymphoma, Follicular, Neoplasms, Lymphatic Diseases, Immunoproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Capacity of sampling
number of samples collected
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start7 Nov 2022
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular 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
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Camille Laurent, MD, Principal investigator, Oncopole - Toulouse FranceKarin Tarte, PhD, Principal investigator, Micro-environnement et cancer (MICA) - Rennes FranceFranck MORSCHHAUSER, MD, Principal investigator, Centre Hospitalier Universitaire de Lille - Lille France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529524
- Sponsor's protocol ID
- CALC
- Status last verified
- Jan 2025
- First submitted
- 2 Sep 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)
- ClinicalTrials.gov ID
- NCT05529524
- Acronym / sponsor ID
- CALC
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma, Mosunetuzomab, Resistance, CD20-CD3, Bispecific antibodies, Neoplasms, Lymphatic Diseases, Immunoproliferative Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 7 Sep 2022 (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.
Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.
Detailed description
the objective is to produce a collection of great scientific interest for lymphoma research from CELESTIMO's clinical trial patients' samples to increase knowledge of treatment with mosunetuzumab's for patients with follicular lymphoma (FL).
study population involves patients participating to CELESTIMO study in France. 10 sites are expected in this biobanking protocol study
Biological samples will collected as part of routine care (tissue and blood already sampled in routine and/or CELESTIMO study) at screening, at C4, at C12 or at progressive disease/relapse.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who participate to CELESTIMO study (NCT04712097)
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
Capacity of sampling
Time frame: 2 years
number of samples collected
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 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Camille Laurent, MD principal investigator
Oncopole - Toulouse France
Karin Tarte, PhD principal investigator
Micro-environnement et cancer (MICA) - Rennes France
Franck MORSCHHAUSER, MD principal investigator
Centre Hospitalier Universitaire de Lille - Lille France
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
Capacity of sampling (time frame: 2 years). 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 Jan 2025.