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

• Conditions: Blood Cancer
• Interventions: Other: Data collection

• Registration Number: NCT05450367
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-05
• Study First Posted: 2022-07-08
• Last Update Posted: 2022-07-08
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with a haematological malignancy treated with immunotherapy	Data collection	-

Primary Outcome Measures

Name	Time	Method
Proportion of complete response	Through study completion, an average of 1 year	Treatment response : Explore the proportion of complete response
Proportion of progress disease	Through study completion, an average of 1 year	Treatment response : Explore the proportion of progress disease
Proportion of partial response	Through study completion, an average of 1 year	Treatment response : Explore the proportion of partial response
Proportion of stable disease	Through study completion, an average of 1 year	Treatment response : Explore the proportion of stable disease

Secondary Outcome Measures

Name	Time	Method
Incidence of grade IV adverse events	Through study completion, an average of 1 year	Toxicity : Explore the cumulative incidence of grade III and IV adverse events
Time interval between the date of initiation treatment and the date of first progression	Through study completion, an average of 1 year	Progression free survival
Incidence of grade III adverse events	Through study completion, an average of 1 year	Toxicity : Explore the cumulative incidence of grade III and IV adverse events
Interruption rates of immunotherapy	Through study completion, an average of 1 year	Toxicity : Explore the interruption and discontinuation rates of immunotherapy
Discontinuation rates of immunotherapy	Through study completion, an average of 1 year	Toxicity : Explore the interruption and discontinuation rates of immunotherapy
Time interval between the date of initiation treatment and the date of death from any cause	Through study completion, an average of 1 year	Overall survival

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital; 🇫🇷 Paris, Ile De France, France