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

Primary Purpose

Hematologic Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hematologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Weight at inclusion < 50 kg 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    experimental:Acute leukemia/myelodysplastic or myeloproliferative disease

    Arm Description

    blood sampling, bone marrow aspirate, and buccal swab

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 10, 2022
    Last Updated
    October 26, 2022
    Sponsor
    Institut Paoli-Calmettes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05602168
    Brief Title
    Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance
    Official Title
    Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    January 2030 (Anticipated)
    Study Completion Date
    January 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Paoli-Calmettes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hematologic Cancer

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    the study is interventional because there are blood samples taken outside the scope of routine care
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
    Arm Type
    Experimental
    Arm Description
    blood sampling, bone marrow aspirate, and buccal swab
    Intervention Type
    Other
    Intervention Name(s)
    experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
    Intervention Description
    blood sampling, bone marrow aspirate and buccal swab
    Primary Outcome Measure Information:
    Title
    Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)
    Description
    establishment of genomic and proteomic signatures as well as transcriptomic and metabolic profiles associated with IT resistance.
    Time Frame
    up to 7 years
    Secondary Outcome Measure Information:
    Title
    to study the resistance to treatments
    Description
    study of the sensitivity to IT in vitro of primary cells from patients
    Time Frame
    up to 7 years
    Title
    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.
    Description
    Establishment of xenografts in immunocompromised mice from primary cells of TI-resistant patients patients resistant to IT
    Time Frame
    up to 7 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Weight at inclusion < 50 kg 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique GENRE, MD
    Phone
    +33491223778
    Email
    drci.up@ipc.unicancer.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

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