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

NCT ID: NCT05602168

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2030-01-31

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.

Detailed Description

It is a collection of blood, marrow and oral epithelial cell samples taken longitudinally and oral epithelial cells taken longitudinally for each patient included, with each patient included, with the corresponding clinical data. An oral epithelial cell sample will be collected at inclusion from 2 swabs, which will allow extraction of DNA from healthy from healthy cells. During blood sampling necessary for care, an additional 40 ml of blood will be collected of 40 ml of blood will be collected in 10 tubes of 4 ml: 4 EDTA tubes, 4 heparinized heparinized tubes and 2 dry tubes. These additional collections will take place at the following times:

• At inclusion
• 7 days (+/- 2 days) after initiation of treatment
• 14 days (+/- 2 days) after initiation of therapy
• 21-42 days after initiation of therapy (early response assessment)
• In case of complete remission
• In case of relapse or progression During bone marrow punctures required for treatment, 6 ml of bone marrow bone marrow will be collected in 2 tubes of 3 ml: 1 EDTA tube and 1 heparinized tube.

heparinized tube. These additional collections will take place at the following times following times:

• At inclusion
• 21-42 days after initiation of treatment (assessment of early response) early response)
• In case of complete remission
• In case of relapse or progression Patients will be followed for up to 2 years after inclusion.

Conditions

Hematologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

blood sampling, bone marrow aspirate, and buccal swab

Group Type: EXPERIMENTAL

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

Intervention Type: OTHER

blood sampling, bone marrow aspirate and buccal swab

Interventions

experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

blood sampling, bone marrow aspirate and buccal swab

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative syndrome according to the WHO classification 2016,

2. Patient for whom a new line of therapy is initiated.

3. Patient older than 18 years of age.

4. Patient affiliated to the social security system or benefiting from such a system.

5. Signed consent to participate.

Exclusion Criteria

1. Weight at inclusion < 50 kg

2. Participating in another clinical study that would cause the total amount of blood collection to exceed the and endanger the patient

3. 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.

4. Impossibility to submit to the medical follow-up of the trial for geographical social or psychological reasons,

5. Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dominique GENRE, MD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Other Identifiers

HEMATOBIO.02-IPC 2021-061

Identifier Type: -

Identifier Source: org_study_id