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

NCT05450367 | Completed

• 1 other identifier: APHP220632
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Cancer

Keywords

Haematologic malignancies; Immunotherapy; Response predictor; Immune-related adverse event

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Incidence of grade III adverse events

  Through study completion, an average of 1 year

• Incidence of grade IV adverse events

  Through study completion, an average of 1 year

• Interruption rates of immunotherapy

  Through study completion, an average of 1 year

• 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

  Through study completion, an average of 1 year

Study Arms (1)

patients with a haematological malignancy treated with immunotherapy

Other: Data collection

Interventions

Data collection OTHER

Data collection

patients with a haematological malignancy treated with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with a haematological malignancy and treated with immunotherapy

You may qualify if:

• 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,

You may not qualify if:

• \- Patients opposed to the collection of their personnal data

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

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

Location

Related Publications (1)

• 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.

  PMID: 37627056 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jeremie Zerbit, PharmD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 8, 2022
• Study Start: August 1, 2017
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)