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

Blood Cancer Clinical Trial

— PRONOSTIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450367
• Other study ID #: APHP220632
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: July 15, 2022

Study information

• Verified date: June 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jeremie Zerbit, PharmD
• Phone: 00 33 1 58 41 41 41
• Email: jeremie.zerbit[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Cancer
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• Data collection
Data collection

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of complete response	Treatment response : Explore the proportion of complete response	Through study completion, an average of 1 year
Primary	Proportion of partial response	Treatment response : Explore the proportion of partial response	Through study completion, an average of 1 year
Primary	Proportion of stable disease	Treatment response : Explore the proportion of stable disease	Through study completion, an average of 1 year
Primary	Proportion of progress disease	Treatment response : Explore the proportion of progress disease	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	Interruption rates of immunotherapy	Toxicity : Explore the interruption and discontinuation rates of immunotherapy	Through study completion, an average of 1 year
Secondary	Discontinuation rates of immunotherapy	Toxicity : Explore the interruption and discontinuation rates of immunotherapy	Through study completion, an average of 1 year
Secondary	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
Secondary	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