CyFluATG in Lower Risk MDS

Trial Title: CyFluATG in Lower Risk MDS

NCT ID: NCT06098326

Condition: Myelodysplastic Syndromes

Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Cyclophosphamide
Fludarabine
Antilymphocyte Serum

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, fludarabine, and antithymocyte globulin
Description: 1. Cyclophosphamide 50 mg/kg/day i.v. daily on days -3 and -2 (for 2 days) 2. Fludarabine 30 mg/m2/day i.v. daily on days -7to -2 (for 6 days) 3. Antithymocyte globulin (Thymoglobulin) 1.5 mg/kg/day (for HLA-matched sibling donor HCT) or 3.0 mg/kg/day (for other alternative donor HCT) i.v. daily on days -3 to -1 (for 3 days)
Arm group label: CyFluATG

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 lower risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of engraftment and non-relapse mortality (NRM).

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 -2 (for 6 days) C. Antithymocyte globulin (Thymoglobulin) 1.5 mg/kg/day (for HLA-matched sibling donor HCT) or 3.0 mg/kg/day (for other alternative donor HCT) i.v. daily on days -3 to -1 (for 3 days) D. Methylprednisolone 2 mg/kg i.v. daily on days -4 to -1 (for 4 days) - Harvest and infusion of donor hematopoietic cells A. Harvested peripheral blood mononuclear cells of donors via leukapheresis will be infused to recipients on day 0. Additional infusion on day 1 can be made based on the judgement of attending physician. - GVHD prophylaxis A. Cyclosporine: 1.5 mg/kg i.v. every 12 hours beginning on day -1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. B. Methotrexate: 15 mg/m2 i.v. on day 1, and 10 mg/m2 i.v. on days 3 and 6.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 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)

Gender: All

Minimum age: 18 Years

Maximum age: 70 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: March 6, 2018

Completion date: December 31, 2026

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/NCT06098326