Safety and efficacy of cord blood transplantation for hematologic malignancies (OCU 9-2)

UMIN ID: UMIN000002214

Registered date:17/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia AML with multilineage dysplasia Myelodysplastic syndrome Acute lymphoblastic leukemia Chronic myeloid leukemia Adult T cell leukemia/lymphoma Malignant lymphoma
• Date of first enrollment: 2009/09/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Myeloablative conditioning regimen consists of Ara-C, cyclophosphamide and TBI12Gy. Nonmyeloablative conditioning regimen consists of fludarabine 180mg/m2, intravenous busulfan 8mg/kg,and TBI 4Gy.

Outcome(s)

• Primary Outcome: Engraftment rate

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Dysfunction of major organ which meets any of the following criteria. a. T-Bil > 2.0mg/dl b. Cre > 2.0mg/dl c. EF >30% d. %VC <30%, FEV1.0% <40% or SaO2 < 50mmHg on room air (SpO2 <90%) e. AST: beyond 3 times of UNL 2. Active infection 3. Poorly controlled diabetes mellitus despite the use of insulin 4. Poorly controlled hypertention 5. Severe complications including heart failure, coronary failure, myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia 6. Pregnant, nursing of possible fertile woman 7. Severe mental disorder who is unlikely to be able to participate in the study 8. A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplantation 9. HIV antibody positivity 10. No indication for this study judged by physician in charge

Related Information

• Primary Sponsor: Hematology, Osaka City University, Graduate School of Medicine
• Source(s) of Monetary Support: Hematology, Osaka City University, Graduate School of Medicine