Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS)

NCT01255319 | Unknown

• 1 other identifier: Allo-038
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility and 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).

Conditions

Myelodysplastic Syndrome

Keywords

MDS

Outcome Measures

Primary Outcomes (1)

• feasibility and efficacy

  To evaluate the feasibility and 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 (the primary endpoints)

  4years

Secondary Outcomes (1)

• progression-free survival, and overall survival

  4 years

Eligibility Criteria

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

Study Population

Patients with lower risk MDS

You may qualify if:

• Patients with lower risk MDS (bone marrow blast percentage \< 5%)
• Patients with appropriate hematopoietic cell donor
• Adequate performance status (Karnofsky score of 70 or more; see Appendix II)
• 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 of 40% or more 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 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)
• 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

Sponsors & Collaborators

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736, South Korea

RECRUITING

Related Links

• Conditioning with cyclophosphamide, fludarabine and antithymocyte globulin for allogeneic hematopoietic cell transplantation in lower risk myelodysplastic syndrome

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Je-Hwan Lee, Doctor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Je-Hwan Lee, Doctor

CONTACT

82-2-3010-3218; jhlee3@amc.seoul.kr

Ya-Eun Jang, Nurse

CONTACT

82-2-3010-6378; redpin75@paran.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2014
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

KR (1)