Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.

NCT ID: NCT05450367

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with a haematological malignancy treated with immunotherapy

Data collection

Intervention Type OTHER

Data collection

Interventions

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Data collection

Data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,

Exclusion Criteria

\- Patients opposed to the collection of their personnal data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremie Zerbit, PharmD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 37627056 (View on PubMed)

Other Identifiers

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APHP220632

Identifier Type: -

Identifier Source: org_study_id

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