Status:
ACTIVE_NOT_RECRUITING
HCT With PTCy in Higher-risk MDS
Lead Sponsor:
Asan Medical Center
Conditions:
Patients With MDS, Acute Myeloid Leukemia (AML) Evolving From MDS, and Chronic Myelomonocytic Leukemia (CMML)
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
Brief Summary
This study is conducted to evaluate the efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation...
Detailed Description
This study is conducted to evaluate the efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation...
Eligibility Criteria
Inclusion
- MDS defined by WHO classification, CMML, or AML evolving from MDS A. International Prognostic Scoring System (IPSS) \> 1.0 or bone marrow blast ≥ 5% at any time points before HCT or B. AML progressed from MDS or C. CMML with bone marrow blast ≥ 5% at any time points before HCT
- Patients receiving first HCT
- Patients with appropriate hematopoietic cell donors A. HLA-matched sibling donor B. Unrelated donor C. HLA-mismatched familial donor
- 15 years old or older , under 75 years
- Adequate performance status (Karnofsky score of 70 or more)
- Adequate hepatic function (AST or ALT \< 3 x upper normal limits and bilirubin \< 1.5 x upper normal limit).
- Adequate renal function (creatinine \< 2.0 mg/dL or creatinine clearance ≥ 50 mL/min)
- Adequate cardiac function (left ventricular ejection fraction ≥ 50% on heart scan or echocardiogram)
- Adequate pulmonary function: DLCO, FEV1, and FVC ≥ 45% predicted by pulmonary function tests
- 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)
- Presence of contraindications to cyclophosphamide (patients receiving pentostatin, symptomatic cystitis, urinary tract obstruction, with a history of hypersensitivity reactions to the component of the drug)
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT06098313
Start Date
July 1 2020
End Date
May 31 2027
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