CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming

JRCT ID: jRCTs041180059

Registered date:28/02/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute myelogenous leukemia or myelodysplastic syndrome
• Date of first enrollment: 11/04/2018
• Target sample size: 108
• Countries of recruitment: Not applicable,Japan
• Study type: Interventional
• Intervention(s): Umbilical cord blood transplantation

Outcome(s)

• Primary Outcome: 2-year disease-free survival

Secondary Outcome

1 Time to hematopoietic recovery
2 Engraftment rate
3 Treatment-related toxicity up to Day 28
4. Oral mucosal toxicity up to Day 42
5. Maximum daily dose of opioid up to Day 42
6. Frequency of occurrence and severity of acute GVHD
7 Frequency of occurrence and severity of chronic GVHD
8 Treatment-related mortality rate at Day 100 and 2 years after transplant
9 Relapse rate in 2 years after transplant
10 Two years after transplantation Overall survival rate
11 Percentage incidence of infection
12 Causes of death

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

1.First stem cell transplantation including autologous or allogeneic.
2.Hematological disease listed below.
-Acute myelogenous leukemia
-Myelodysplastic syndrome, RAEB-1 or RAEB-2. Either intermediate-II or high in IPSS. High or very-high in WPSS. Relapsed after CR.
3.Obtained informed consent
4.Performance status 0,1,2
5.appropriate cord blood is available
6.appropriate organ function

Exclude criteria

1.HBs antigen positive
2.HCV antibody positive
3.HIV antibody positive
4 Donor-specific anti-HLA antibody positive
5.Use of gemtuzumab ozogamicin within 6 months before transplantation
6.During pregnant or breast-feeding
7. Uncontrollable psychiatric disorder
8. Uncontrollable infection
9. Allergy for any drug used in the conditioning regimen or GVHD-prophylaxis
10.Considered to be unfit for the study enrollment by the physician

Related Information

• Primary Sponsor: Terakura Seitaro
• Secondary Sponsor: Satoshi Takahashi,,The Japan Society of Hematopoietic Cell Transplantation
• Secondary ID(s): UMIN000029947