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

• Sponsor: Institut Paoli-Calmettes (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05602168
• Collaborator: (none)
• Enrollment: 400
• Arm: 1
• Anticipated Duration (Months): 84

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Cancer	Other: experimental:Acute leukemia/myelodysplastic or myeloproliferative disease	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: the study is interventional because there are blood samples taken outside the scope of routine carethe study is interventional because there are blood samples taken outside the scope of routine care
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2030
• Anticipated Study Completion Date: Jan 1, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping) [up to 7 years]

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

Secondary Outcome Measures

1. to study the resistance to treatments [up to 7 years]

   study of the sensitivity to IT in vitro of primary cells from patients

2. 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]

   Establishment of xenografts in immunocompromised mice from primary cells of TI-resistant patients patients resistant to IT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Institut Paoli-Calmettes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT05602168
• Other Study ID Numbers: HEMATOBIO.02-IPC 2021-061
• First Posted: Nov 1, 2022
• Last Update Posted: Nov 1, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hematologic Neoplasms

Study Results

No Results Posted as of Nov 1, 2022