Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance

NCT05602168 | Not Yet Recruiting

• 1 other identifier: HEMATOBIO.02-IPC 2021-061
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.

Conditions

Hematologic Cancer

Outcome Measures

Primary Outcomes (1)

• Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)

  establishment of genomic and proteomic signatures as well as transcriptomic and metabolic profiles associated with IT resistance.

  up to 7 years

Secondary Outcomes (2)

• to study the resistance to treatments

  up to 7 years

• Creation of murine cell models (Patient-derived xenografts, PDX) from patient blasts to study in vivo in order to study in vivo the mechanisms of resistance to treatment.

  up to 7 years

Study Arms (1)

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

EXPERIMENTAL

blood sampling, bone marrow aspirate, and buccal swab

Other: experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

Interventions

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease OTHER

blood sampling, bone marrow aspirate and buccal swab

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

Eligibility Criteria

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

You may qualify if:

• Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative syndrome according to the WHO classification 2016,
• Patient for whom a new line of therapy is initiated.
• Patient older than 18 years of age.
• Patient affiliated to the social security system or benefiting from such a system.
• Signed consent to participate.

You may not qualify if:

• Participating in another clinical study that would cause the total amount of blood collection to exceed the and endanger the patient
• Person in an emergency situation, adult under legal protection (guardianship, curatorship, etc.) protection (guardianship, curatorship or safeguard of justice), or unable to express his or her consent.
• Impossibility to submit to the medical follow-up of the trial for geographical social or psychological reasons,
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dominique GENRE, MD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the study is interventional because there are blood samples taken outside the scope of routine care

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 1, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 1, 2022

Record last verified: 2022-10