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NCT Number: NCT05450367

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

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.

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Key information

Conditions

Blood Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, Île-de-France Region, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Data collection

Primary outcomes

  1. Proportion of complete response

    Time frame: Through study completion, an average of 1 year

    Treatment response : Explore the proportion of complete response

  2. Proportion of partial response

    Time frame: Through study completion, an average of 1 year

    Treatment response : Explore the proportion of partial response

  3. Proportion of stable disease

    Time frame: Through study completion, an average of 1 year

    Treatment response : Explore the proportion of stable disease

  4. Proportion of progress disease

    Time frame: Through study completion, an average of 1 year

    Treatment response : Explore the proportion of progress disease

Secondary outcomes

  1. Incidence of grade III adverse events

    Time frame: Through study completion, an average of 1 year

    Toxicity : Explore the cumulative incidence of grade III and IV adverse events

  2. Incidence of grade IV adverse events

    Time frame: Through study completion, an average of 1 year

    Toxicity : Explore the cumulative incidence of grade III and IV adverse events

  3. Interruption rates of immunotherapy

    Time frame: Through study completion, an average of 1 year

    Toxicity : Explore the interruption and discontinuation rates of immunotherapy

  4. Discontinuation rates of immunotherapy

    Time frame: Through study completion, an average of 1 year

    Toxicity : Explore the interruption and discontinuation rates of immunotherapy

  5. Time interval between the date of initiation treatment and the date of first progression

    Time frame: Through study completion, an average of 1 year

    Progression free survival

  6. 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

    Overall survival

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: PRONOSTIM

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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