Back to resultsHLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies (MICROSTEM)
Primary Purpose
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
HLA-mismatched microtransplantation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Microtransplantation, Myeloid Hemopathy
Eligibility Criteria
Inclusion Criteria:
- Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning)
- HLA-partially matched family donors
- Affiliated to(or beneficiary of) the Social Security
- Informed consent signed
Exclusion Criteria:
- AML3
- Previous Hematopoietic Stem Cell TRansplantation
- Uncontrolled infection -PS>3 -Other progressive cancer
- Psychiatric disease
- Vulnerable person or unable to provide informed consent
- Emergency
- Unable to comply with required study follow up
Sites / Locations
- Institut Paoli CalmettesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLA-mismatched microtransplantation
Arm Description
HLA-mismatched microtransplantation without immunosuppressive treatment
Outcomes
Primary Outcome Measures
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Cumulative incidence of acute GVH (grade 1 to 4)
Secondary Outcome Measures
Full Information
NCT ID
NCT03232268
First Posted
July 25, 2017
Last Updated
October 11, 2021
Sponsor
Institut Paoli-Calmettes
1. Study Identification
Unique Protocol Identification Number
NCT03232268
Brief Title
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
Acronym
MICROSTEM
Official Title
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
March 8, 2022 (Anticipated)
Study Completion Date
March 8, 2025 (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
Yes
5. Study Description
Brief Summary
This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Keywords
Microtransplantation, Myeloid Hemopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLA-mismatched microtransplantation
Arm Type
Experimental
Arm Description
HLA-mismatched microtransplantation without immunosuppressive treatment
Intervention Type
Biological
Intervention Name(s)
HLA-mismatched microtransplantation
Intervention Description
3 administrations of hematopoietic stem cells without immunosupression
Primary Outcome Measure Information:
Title
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Description
Cumulative incidence of acute GVH (grade 1 to 4)
Time Frame
100 days after transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning)
HLA-partially matched family donors
Affiliated to(or beneficiary of) the Social Security
Informed consent signed
Exclusion Criteria:
AML3
Previous Hematopoietic Stem Cell TRansplantation
Uncontrolled infection -PS>3 -Other progressive cancer
Psychiatric disease
Vulnerable person or unable to provide informed consent
Emergency
Unable to comply with required study follow up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Genre, MD
Phone
+ 33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jihane Pakradouni
Phone
+ 33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Bouches Du Rhône
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique GENRE, MD
Phone
33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jihane Pakradouni, PharmD PhD
Phone
33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Faezeh Izadifar Legrand
12. IPD Sharing Statement
Learn more about this trial
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
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