HCT With PTCy in Higher-risk MDS

Trial Title: HCT With PTCy in Higher-risk MDS

NCT ID: NCT06098313

Condition: Patients With MDS, Acute Myeloid Leukemia (AML) Evolving From MDS, and Chronic Myelomonocytic Leukemia (CMML)

Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Cyclophosphamide

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: -Cyclophosphamide 50 mg/kg/day i.v. daily on days 3 and 4 (for 2 days)
Arm group label: PTCy

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 (HCT) in patients with higher-risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of the GVHD-free, relapse-free survival. The secondary end points of the study include engraftment, relapse incidence, non-relapse mortality, graft-versus-host disease, donor chimerism, immune reconstitution, infections, and survivals (overall and event-free).

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 (HCT) in patients with higher-risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of the GVHD-free, relapse-free survival. The secondary end points of the study include engraftment, relapse incidence, non-relapse mortality, graft-versus-host disease, donor chimerism, immune reconstitution, infections, and survivals (overall and event-free).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Criteria: - 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)

Gender: All

Minimum age: 15 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Asan Medical Center, University of Ulsan College of Medicine

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Start date: July 1, 2020

Completion date: May 31, 2027

Lead sponsor:
Agency: Asan Medical Center
Agency class: Other

Source: Asan Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06098313