Status:
ACTIVE_NOT_RECRUITING
CyFluATG in Lower Risk MDS
Lead Sponsor:
Asan Medical Center
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of the conditioning regimen with cyclophosphamide, fludarabine, and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with ...
Detailed Description
* This is a prospective, phase 2 extension study * Conditioning regimen A. Cyclophosphamide 50 mg/kg/day i.v. daily on days -3 and -2 (for 2 days) B. Fludarabine 30 mg/m2/day i.v. daily on days -7to -...
Eligibility Criteria
Inclusion
- Patients with lower risk MDS A. International prognosticscoring system (IPSS) ≤ 1.0 and B. Bone marrow blast percentage \< 5% during the disease course before HCT
- Patients with appropriate hematopoietic cell donor A. HLA-matched sibling B. HLA-matched unrelated donor C. HLA-mismatched familial donor
- 18 years old or older, 70 years old or younger
- Adequate performance status (Karnofsky score of 70 or more)
- Adequate hepatic and renal function (AST, ALT, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dL).
- Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiogram)
- Signed and dated informed consent must be obtained from both recipient and donor.
Exclusion
- Presence of significant active infection
- Presence of uncontrolled bleeding
- Any coexisting major illness or organ failure
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06098326
Start Date
March 6 2018
End Date
December 31 2026
Last Update
October 24 2023
Active Locations (1)
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1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea, 05505