Phase II study of cord blood transplantation using myeloablative conditioning in adult patiants (C-SHOT 0603)

UMIN ID: UMIN000000868

Registered date:29/10/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Acute leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome
• Date of first enrollment: 2007/10/01
• Target sample size: 28
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Conditioning regimen for cord blood transplant was twelve gray (Gy) total body irradiation (TBI), Cyclophosphamide (CPA) and high dose Ara-C with G-CSF for myeloid hematological malignant diseases, and 12 Gy TBI, CPA and high dose Ara-C for lymphoid hematological malignant diseases. Cyclosporine (10 hours continuous) and short-term Methotrexate (MTX; 15 mg/m2 Day 1, 10 mg/m2 Days 3, 6) are used for GVHD prophylaxis. Eligible single cord blood unit is infused without processing on the day of transplant (Day 0) after rapid thawing in 37 degree Celsius thermostat bath.

Outcome(s)

• Primary Outcome: Event-free survival at one year after cord blood transplantation
• Secondary Outcome: 1.Incidence and time of engraftment 2.Incidence and severity of acute GVHD 3.Incidence and severity of chronic GVHD 4.Disease-free survival and overall survival 5.Causes and incidence of sever toxicity 6.Incidence of relapse 7.Incidence of treatment-related toxicity (TRM) 8.Analysis of incidences of TRM between institutions

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 55years-old
• Gender: Male and Female
• Exclude criteria: 1.Active disease in central nerve system. 2.Uncontrollable diabetes 3.Uncontrollable hypertension 4.Active infection 5.Positive for TPHA or HBs antigen 6.Positive for HIV antibody 7.Malignancies addition to primary hematological malignant disease 8.Pregnant or during breast feeding 9.History of stem cell transplantation including autologous transplantation 10.Uncontrollable psycho-neurological symptoms 11.Physician's decision that it is not appropriate to register the patient to this study for other reasons

Related Information

• Primary Sponsor: Research Grant on Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
• Source(s) of Monetary Support: Research Grant on Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare