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

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 Overview

• Status: Completed
• Conditions: Blood Cancer
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 249

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with a haematological malignancy and treated with immunotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with a haematological malignancy treated with immunotherapy	Other: Data collection; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of complete response	Treatment response : Explore the proportion of complete response	Through study completion, an average of 1 year
Proportion of partial response	Treatment response : Explore the proportion of partial response	Through study completion, an average of 1 year
Proportion of stable disease	Treatment response : Explore the proportion of stable disease	Through study completion, an average of 1 year
Proportion of progress disease	Treatment response : Explore the proportion of progress disease	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grade III adverse events	Toxicity : Explore the cumulative incidence of grade III and IV adverse events	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	Through study completion, an average of 1 year
Interruption rates of immunotherapy	Toxicity : Explore the interruption and discontinuation rates of immunotherapy	Through study completion, an average of 1 year
Discontinuation rates of immunotherapy	Toxicity : Explore the interruption and discontinuation rates of immunotherapy	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	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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Jeremie Zerbit, PharmD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; Haematologic malignancies; Immune-related adverse event; Response predictor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: APHP220632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No