Hematopoietic Cell Transplantation With Post-transplantation Cyclophosphamide in MDS

NCT02969980 | Completed Phase 2

• 1 other identifier: MDS_PTCy_2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to evaluate the feasibility and efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation (HCT) in patients with myelodysplastic syndrome (MDS).

Conditions

Myelodysplastic Syndromes

Keywords

MDS; AML progressed from MDS; CMML

Outcome Measures

Primary Outcomes (1)

• the incidence of acute and chronic graft-versus-host disease

  100 days and 2 year, respectively

Study Arms (1)

PTCy

EXPERIMENTAL

Patients who receive post-transplantation cyclophosphamide

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

Cyclophosphamide 50 mg/kg/day i.v. daily on days 3 and 4 of hematopoietic cell transplantation

PTCy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• MDS defined by WHO classification, chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) evolving from MDS A. IPSS \> 1.0 or bone marrow blast ≥ 5% at any time points before HCT or B. AML progressed from MDS or C. CMML
• Patients receiving first HCT
• Patients with appropriate hematopoietic cell donors A. HLA-matched sibling donor B. Unrelated donor C. HLA-mismatched familial donor
• years old or older
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Professor

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

KR (1)