Back to resultsExtension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen (HaploMUD-RIC)
Primary Purpose
Acute Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hematopoietic stem cells transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Leukemia
Eligibility Criteria
Inclusion Criteria:
- Patients with hematological malignancy
- Age<55 years
- HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
- Patients without a matched related donor
- Patients eligible for an allogeneic HSCT from an alternative donor
- Able to comply with the protocol
- Written informed consent
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion Criteria:
- Clinical or biological contraindication to allogeneic HSCT
- Pregnant or breast-feeding women.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
- Severe concomitant disease
Sites / Locations
- Institut Paoli-Calmettes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
haploidentical related donors
Matched unrelated donor
Arm Description
Outcomes
Primary Outcome Measures
Event-free survival
the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03595800
Brief Title
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
Acronym
HaploMUD-RIC
Official Title
Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2022 (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
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
haploidentical related donors
Arm Type
Experimental
Arm Title
Matched unrelated donor
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic stem cells transplantation
Intervention Description
Allogeneic Hematopoietic stem cells transplantation
Primary Outcome Measure Information:
Title
Event-free survival
Description
the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with hematological malignancy
Age<55 years
HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
Patients without a matched related donor
Patients eligible for an allogeneic HSCT from an alternative donor
Able to comply with the protocol
Written informed consent
Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion Criteria:
Clinical or biological contraindication to allogeneic HSCT
Pregnant or breast-feeding women.
Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Severe concomitant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia Harbi, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier Blaise
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
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