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

Hematologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05602168
• Other study ID #: HEMATOBIO.02-IPC 2021-061
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: January 2030

Study information

• Verified date: October 2022
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Cancer
• Hematologic Neoplasms

Intervention

Other:
• experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
blood sampling, bone marrow aspirate and buccal swab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to study the resistance to treatments	study of the sensitivity to IT in vitro of primary cells from patients	up to 7 years
Secondary	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