Status:
TERMINATED
Randomized Clinical Study Assessing Haplo vs. URD in AML
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Skane University Hospital
Uppsala University Hospital
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the...
Detailed Description
This is a randomized, intention-to-treat, open label, non-inferiority study performed in an international multicenter setting comparing allogeneic stem cell transplantation (SCT) with haplo-identical ...
Eligibility Criteria
Inclusion
- 1\. Adult patients (age ≥ 18 years) with de novo or treatment-related AML, eligible and fit for SCT treatment according to national/international guidelines.
- 2\. One or more potential haplo-identical related donor(s) AND five or more potential 6/6 HLA-A, -B, and -DRB1 antigen matched unrelated donors identified before randomization.
- 3\. Karnofsky Performance Status ≥ 70% at randomization.
- 4\. Signed informed consent.
- 5\. Patient willing and able to comply with protocol requirements
Exclusion
- 1\. Patients with a suitable HLA-identical sibling donor.
- 2\. Patients with \< 5 potential HLA-A, -B, and -DRB1 antigen matched URDs available.
- 3\. Patients with no potential haplo-identical related donor available.
- 4\. Patients scheduled for/receiving cord blood stem cell transplantation.
- 5\. Prior allogeneic SCT using any hematopoietic stem cell source.
- 6\. Patients seropositive for HIV.
- 7\. Pregnancy (positive β-HCG test) within 4 weeks of study entry.
- 8\. Cardiac ejection fraction \< 45%.
- 9\. Karnofsky Performance Status \< 70% at time of randomization.
- 10\. The presence of any psychological, family-related, social, and/or geographical condition potentially jeopardizing compliance with the study protocol and follow-up schedule.
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04067180
Start Date
November 12 2019
End Date
August 26 2022
Last Update
April 5 2023
Active Locations (9)
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1
Medical University of Vienna
Vienna, Austria, 1090
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
3
Oslo University Hospital
Oslo, Norway, NO-0424
4
Pavlov First Saint-Petersburg State Medical University
Saint Petersburg, Russia, 197022