Status:
COMPLETED
Allogeneic HCT Using Conditioning Regimen of BuFluATG for AML CR1
Lead Sponsor:
Asan Medical Center
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
16-75 years
Brief Summary
1. Study Objectives * To evaluate the effect of various clinical variables including HLA-disparity and NK cell-related variables, upon outcomes of allogeneic hematopoietic cell transplantation (HC...
Detailed Description
1.0 STUDY OBJECTIVES To evaluate the effect of various clinical variables including HLA-disparity and NK cell-related variables upon outcomes of allogeneic hematopoietic cell transplantation (HCT) in...
Eligibility Criteria
Inclusion
- 1. Patients with non-promyelocytic AML, intermediate- or poor-risk categories by NCCN ver 2 (2016) guidelines (Appendix I), who achieve CR after induction chemotherapy.
- 2. Patients should be 16 years of age or more, and 75 years of age or less. 3.4. The performance status of the patients should be 70 or over by Karnofsky performance scale (Appendix II).
- 5. Patients should have adequate hepatic function (bilirubin less than 2.0 mg/dl, AST less than three times the upper normal limit).
- 6. Patients must have adequate renal function (creatinine less than 2.0 mg/dl).
- 7. Patients must have adequate cardiac function (ejection fraction \> 40% on MUGA scan).
- 8. Patients must sign informed consent.
- Donor selection process (See appendix III)
- 9. Donor selection process may begin before or when the patients achieve CR. 3.9.1. If a patient has a willing HLA-matched sibling of 65 years or younger, that sibling will be a cell donor.
- 9.2. If a patient has no HLA-matched sibling of 65 years or younger, but a willing HLA- matched unrelated donor is available (younger than 55 years as regulated by KMDP), this will be a cell donor. The donor must be matched with the patient for 7-8 of 8 HLA-A, -B, -C, and -DRB1 allele match.
- 9.3. If a patient does not have an HLA-matched sibling nor unrelated donor, but an HLA- haplotype mismatched family member (offspring, parents, haploidentical sibling) available, this will be a cell donor.
- 9.4. Hematopoietic cell donor must sign informed consent.
Exclusion
- Patients who do not meet the inclusion criteria
- \-
Key Trial Info
Start Date :
April 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT07155382
Start Date
April 4 2017
End Date
August 22 2024
Last Update
September 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea