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Clinical Trials/NCT03232268
NCT03232268CompletedPhase 1

HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

Institut Paoli-Calmettes1 site in 1 country25 target enrollmentStarted: March 9, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •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

Arms & Interventions

HLA-mismatched microtransplantation

Experimental

HLA-mismatched microtransplantation without immunosuppressive treatment

Intervention: HLA-mismatched microtransplantation (Biological)

Outcomes

Primary Outcomes

Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment

Time Frame: 100 days after transplantation

Cumulative incidence of acute GVH (grade 1 to 4)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institut Paoli-Calmettes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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