Blood CancerPRONOSTIMNCT05450367
Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.
An observational study of Blood Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Immunotherapies have substantially improved the prognosis of patients with haematological malignancies. While clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Cancer
- What is being tested?
- Data collection
- How many people
- 249 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2017to 15 Jul 2022
- 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: Adult patients diagnosed with a haematological malignancy and treated with immunotherapy
Who may be able to join
- adult >or= 18 years old,
- Suffering from one of the following pathologies: Hodgkin's lymphoma, Diffuse large B-cell lymphoma, Mantle B-cell lymphoma, Acute myeloid leukemia, Acute lymphoid leukemia, Peripheral T-cell lymphoma,
- Patients treated wuth any of the following immunotherapy : nivolumab, pembrolizumab, brentuximab vedotin, axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, gentuzumab ozogamicine, polatuzumab vedotin and blinatumomab,
Who cannot join
- Patients opposed to the collection of their personnal data
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital
Paris, Île-de-France Region, 75014
About this study
Immunotherapies have substantially improved the prognosis of patients with haematological malignancies. While clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. The identification of predictive markers using demographic, physiologic, biologic, immunologic data as well as patients' treatment history, might enable the optimization of therapeutic sequences and the reduction of treatment toxicity.
This study aim to assess markers of toxicity and response following an immunotherapy in patients with a haematological malignancy using real life data.
It will allow the development of clinical and therapeutic benchmarks to guide medical decisions in relation to the therapeutic strategies to be implemented for patients benefiting from real-life conditions, in addition to the results obtained in randomized studies.
- Conditions
- Blood Cancer
- Being tested
- Data collection
- Keywords
- Haematologic malignancies, Immunotherapy, Response predictor, Immune-related adverse event
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| patients with a haematological malignancy treated with immunotherapy | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complete response
Treatment response : Explore the proportion of complete response
Measured: Through study completion, an average of 1 year
Proportion of partial response
Treatment response : Explore the proportion of partial response
Measured: Through study completion, an average of 1 year
Proportion of stable disease
Treatment response : Explore the proportion of stable disease
Measured: Through study completion, an average of 1 year
Proportion of progress disease
Treatment response : Explore the proportion of progress disease
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Incidence of grade III adverse events
Toxicity : Explore the cumulative incidence of grade III and IV adverse events
Measured: Through study completion, an average of 1 year
Incidence of grade IV adverse events
Toxicity : Explore the cumulative incidence of grade III and IV adverse events
Measured: Through study completion, an average of 1 year
Interruption rates of immunotherapy
Toxicity : Explore the interruption and discontinuation rates of immunotherapy
Measured: Through study completion, an average of 1 year
Discontinuation rates of immunotherapy
Toxicity : Explore the interruption and discontinuation rates of immunotherapy
Measured: Through study completion, an average of 1 year
Time interval between the date of initiation treatment and the date of first progression
Progression free survival
Measured: Through study completion, an average of 1 year
Time interval between the date of initiation treatment and the date of death from any cause
Overall survival
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Aug 2017
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jeremie Zerbit, PharmD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450367
- Sponsor's protocol ID
- APHP220632
- Acronym
- PRONOSTIM
- Status last verified
- Sep 2025
- First submitted
- 27 Jun 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Detroit M, Collier M, Beeker N, Willems L, Decroocq J, Deau-Fischer B, Vignon M, Birsen R, Moufle F, Leclaire C, Balladur E, Deschamps P, Chauchet A, Batista R, Limat S, Treluyer JM, Ricard L, Stocker N, Hermine O, Choquet S, Morel V, Metz C, Bouscary D, Kroemer M, Zerbit J. Predictive Factors of Response to Immunotherapy in Lymphomas: A Multicentre Clinical Data Warehouse Study (PRONOSTIM). Cancers (Basel). 2023 Aug 9;15(16):4028. doi: 10.3390/cancers15164028.
PubMed 37627056
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.
- ClinicalTrials.gov ID
- NCT05450367
- Acronym / sponsor ID
- PRONOSTIM / APHP220632
- Conditions
- Blood Cancer
- Keywords
- Haematologic malignancies, Immunotherapy, Response predictor, Immune-related adverse event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 8 Jul 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.
Immunotherapies have substantially improved the prognosis of patients with haematological malignancies. While clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. The identification of predictive markers using demographic, physiologic, biologic, immunologic data as well as patients' treatment history, might enable the optimization of therapeutic sequences and the reduction of treatment toxicity.
This study aim to assess markers of toxicity and response following an immunotherapy in patients with a haematological malignancy using real life data.
It will allow the development of clinical and therapeutic benchmarks to guide medical decisions in relation to the therapeutic strategies to be implemented for patients benefiting from real-life conditions, in addition to the results obtained in randomized studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a haematological malignancy treated with immunotherapy | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with a haematological malignancy and treated with immunotherapy
Key inclusion criteria (3 listed)
- adult >or= 18 years old,
- Suffering from one of the following pathologies: Hodgkin's lymphoma, Diffuse large B-cell lymphoma, Mantle B-cell lymphoma, Acute myeloid leukemia, Acute lymphoid leukemia, Peripheral T-cell lymphoma,
- Patients treated wuth any of the following immunotherapy : nivolumab, pembrolizumab, brentuximab vedotin, axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, gentuzumab ozogamicine, polatuzumab vedotin and blinatumomab,
Key exclusion criteria (1 listed)
- Patients opposed to the collection of their personnal data
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 |
|---|---|---|
| Data collectionData collection | Other | patients with a haematological malignancy treated with immunotherapy |
Primary outcome
Proportion of complete response
Time frame: Through study completion, an average of 1 year
Treatment response : Explore the proportion of complete response
Proportion of partial response
Time frame: Through study completion, an average of 1 year
Treatment response : Explore the proportion of partial response
Proportion of stable disease
Time frame: Through study completion, an average of 1 year
Treatment response : Explore the proportion of stable disease
Proportion of progress disease
Time frame: Through study completion, an average of 1 year
Treatment response : Explore the proportion of progress disease
6 secondary outcomes
Incidence of grade III adverse events
Time frame: Through study completion, an average of 1 year
Incidence of grade IV adverse events
Time frame: Through study completion, an average of 1 year
Interruption rates of immunotherapy
Time frame: Through study completion, an average of 1 year
Discontinuation rates of immunotherapy
Time frame: Through study completion, an average of 1 year
Time interval between the date of initiation treatment and the date of first progression
Time frame: Through study completion, an average of 1 year
Time interval between the date of initiation treatment and the date of death from any cause
Time frame: Through study completion, an average of 1 year
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 12 Sep 2025.
- Results publication: PubMed 37627056Detroit M, Collier M, Beeker N, Willems L, Decroocq J, Deau-Fischer B, Vignon M, Birsen R, Moufle F, Leclaire C, Balladur E, Deschamps P, Chauchet A, Batista R, Limat S, Treluyer JM, Ricard L, Stocker N, Hermine O, Choquet S, Morel V, Metz C, Bouscary D, Kroemer M, Zerbit J. Predictive Factors of Response to Immunotherapy in Lymphomas: A Multicentre Clinical Data Warehouse Study (PRONOSTIM). Cancers (Basel). 2023 Aug 9;15(16):4028. doi: 10.3390/cancers15164028.
- 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.
Jeremie Zerbit, PharmD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Blood Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 1 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 12 Sep 2025. 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 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?
Proportion of complete response (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450367, which also lists 1 linked publication.
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 12 Sep 2025.