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

Information source: Cooperative Study Group A for Hematology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndrome

Phase: N/A

Status: Recruiting

Sponsored by: Cooperative Study Group A for Hematology

Official(s) and/or principal investigator(s):
Je-Hwan Lee, Doctor, Principal Investigator, Affiliation: Asan Medical Center

Overall contact:
Je-Hwan Lee, Doctor, Phone: 82-2-3010-3218, Email: jhlee3@amc.seoul.kr

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).

Clinical Details

Official title: Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: feasibility and efficacy

Secondary outcome: progression-free survival, and overall survival

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)

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Je-Hwan Lee, Doctor, Phone: 82-2-3010-3218, Email: jhlee3@amc.seoul.kr

Asan Medical Center, Seoul, Asanbyeongwon-gil, songpa-gu 138-736, Korea, Republic of; Recruiting
Yae-Eun Jang, nurse, Phone: 82-2-3010-6378, Email: redpin75@paran.com
Additional Information

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

Starting date: November 2010
Last updated: December 6, 2010

Page last updated: August 20, 2015

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