PRONOSTIM: Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| patients with a haematological malignancy treated with immunotherapy
|
Other: Data collection
Data collection
|
Outcome Measures
Primary Outcome Measures
- Proportion of complete response [Through study completion, an average of 1 year]
Treatment response : Explore the proportion of complete response
- Proportion of partial response [Through study completion, an average of 1 year]
Treatment response : Explore the proportion of partial response
- Proportion of stable disease [Through study completion, an average of 1 year]
Treatment response : Explore the proportion of stable disease
- Proportion of progress disease [Through study completion, an average of 1 year]
Treatment response : Explore the proportion of progress disease
Secondary Outcome Measures
- Incidence of grade III adverse events [Through study completion, an average of 1 year]
Toxicity : Explore the cumulative incidence of grade III and IV adverse events
- Incidence of grade IV adverse events [Through study completion, an average of 1 year]
Toxicity : Explore the cumulative incidence of grade III and IV adverse events
- Interruption rates of immunotherapy [Through study completion, an average of 1 year]
Toxicity : Explore the interruption and discontinuation rates of immunotherapy
- Discontinuation rates of immunotherapy [Through study completion, an average of 1 year]
Toxicity : Explore the interruption and discontinuation rates of immunotherapy
- Time interval between the date of initiation treatment and the date of first progression [Through study completion, an average of 1 year]
Progression free survival
- Time interval between the date of initiation treatment and the date of death from any cause [Through study completion, an average of 1 year]
Overall survival
Eligibility Criteria
Criteria
Inclusion Criteria :
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adult >or= 18 years old,
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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,
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Patients treated wuth any of the following immunotherapy : nivolumab, pembrolizumab, brentuximab vedotin, axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, gentuzumab ozogamicine, polatuzumab vedotin and blinatumomab,
Exclusion Criteria :
- Patients opposed to the collection of their personnal data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital | Paris | Ile De France | France | 75014 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Jeremie Zerbit, PharmD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP220632