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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Blood Cancer

Treatments

Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT05450367
APHP220632

Details and patient eligibility

About

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.

Enrollment

249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

249 participants in 1 patient group

patients with a haematological malignancy treated with immunotherapy
Treatment:
Other: Data collection

Trial contacts and locations

1

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Central trial contact

Jeremie Zerbit, PharmD; Marie BENHAMMANI-GODARD

Data sourced from clinicaltrials.gov

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