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

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Cancer

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with a haematological malignancy treated with immunotherapy<br> | Other: Data collection<br>* Data collection<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haematologic malignancies, Immunotherapy, Response predictor, Immune-related adverse event