HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic diseases

UMIN ID: UMIN000002069

Registered date:12/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia(AML) Acute lymphoblastic leukemia (ALL) Secondary acute myelogenous leukemia Chronic myeloid leukemia (CML) Myelodysplastic syndrome (MDS)
• Date of first enrollment: 2009/12/25
• Target sample size: 17
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Fludarabine(15mg/square meter of body surface area twice a day for 2 days and 30mg/square meter once a day for 4 days), cytarabine(2g/square meter twice a day for 2 days), buslufan(0.8mg/kg 4 times a day for 4 days) and ATG(2mg/kg per day for 2days) is used as a conditioning regimen. (If a patient has a history of using Busulfan as a conditioning regimen of previous transplantation, Melphalan(100mg/ square meter per day for 1 day) is used instead of Busulfan.) Cyclophosphamide (25mg/kg)is used on day3, 4 after the graft infusion. The donor source is peripheral blood stem cell. Patients receive cotinuous intravenous tacrolimus (0.03mg/kg/day) and mycophenolate mofetil 3000mg/day from day4 after hematopoietic stem cell transplantation.

Outcome(s)

• Primary Outcome: Engraftment rate

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Major organ dysfunction a) Total bilirubin: >= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: < 50 % d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air e) AST or ALT >= 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia 7) Pregnant, nursing or possible fertile woman 8) Patients with severe mental disorder who are likely to unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplant 10) HIV antibody positivity 11) No indication for this study judged by physician in charge. (Note: HBs antigen positivity and HCV antibody positivity is not excluded.)

Related Information

• Primary Sponsor: Hematology, Osaka City University, Graduate School of Medicine
• Source(s) of Monetary Support: None