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

Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Cancer
• Intervention / Treatment: Other: experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental:Acute leukemia/myelodysplastic or myeloproliferative disease; blood sampling, bone marrow aspirate, and buccal swab	Other: experimental:Acute leukemia/myelodysplastic or myeloproliferative disease; blood sampling, bone marrow aspirate and buccal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
to study the resistance to treatments	study of the sensitivity to IT in vitro of primary cells from patients	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.	Establishment of xenografts in immunocompromised mice from primary cells of TI-resistant patients patients resistant to IT	up to 7 years

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2030
• Study Completion (Anticipated): January 1, 2030

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: HEMATOBIO.02-IPC 2021-061

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No