Clinical trial NCT05450367: Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.
Official title: Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Cancer
Keywords: Haematologic malignancies
Immunotherapy
Response predictor
Immune-related adverse event
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with a haematological malignancy and treated with immunotherapy

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.


Eligibility 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

Primary outcomes:
measure: Proportion of complete response
timeFrame: Through study completion, an average of 1 year
measure: Proportion of partial response
timeFrame: Through study completion, an average of 1 year
measure: Proportion of stable disease
timeFrame: Through study completion, an average of 1 year
measure: Proportion of progress disease
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence of grade III adverse events
timeFrame: Through study completion, an average of 1 year
measure: Incidence of grade IV adverse events
timeFrame: Through study completion, an average of 1 year
measure: Interruption rates of immunotherapy
timeFrame: Through study completion, an average of 1 year
measure: Discontinuation rates of immunotherapy
timeFrame: Through study completion, an average of 1 year
measure: Time interval between the date of initiation treatment and the date of first progression
timeFrame: Through study completion, an average of 1 year
measure: Time interval between the date of initiation treatment and the date of death from any cause
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jeremie Zerbit, PharmD
role: PRINCIPAL_INVESTIGATOR
References: