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

NCT ID: NCT01255319

Last Updated: 2010-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-11-30

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).

Detailed Description

Conditioning therapy

• Cytoxan 50 mg/kg/d on d-3 to -2
• Fludarabine 30 mg/m2 on d-6 to -2
• Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT)
• Methylpd 2 mg/kg/d on d-4 to -1

Mobilization and harvest

• G-CSF 10 mcg/kg/d s.c. on d-3 to 0
• Harvest of PBMCs on d 0 to +1

Donor G PBMC infusion

• Infuse G-PBMCs on d 0 to d+1.

GVHD prophylaxis

• Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
• Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Preemptive dose-escalating DLIs

• Begin at d+120 or at least 2 wks after IST discontinuation.
• Failure to achieve full donor chimerism No evidence of GVHD
• CD3+ cell dose increment q 4 wks -+ cell dose: HLA-matched donor HCT (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), HLA-matched unrelated donor HCT (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), HLA-matched familial donor HCT (1 x 105/kg, 5 x 105/kg, 1 x 106/kg)

Conditions

Myelodysplastic Syndrome

Keywords

MDS

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cooperative Study Group A for Hematology

NETWORK

Sponsor Role: lead

Responsible Party

Cooperative Study Group A for Hematology

Principal Investigators

Je-Hwan Lee, Doctor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

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

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Je-Hwan Lee, Doctor

Role: CONTACT

Phone: 82-2-3010-3218

Email: jhlee3@amc.seoul.kr

Ya-Eun Jang, Nurse

Role: CONTACT

Phone: 82-2-3010-6378

Email: redpin75@paran.com

Facility Contacts

Yae-Eun Jang, nurse

Role: primary

Related Links

http://www.google.co.kr

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

Other Identifiers

Allo-038

Identifier Type: -

Identifier Source: org_study_id