A pilot phase I study of azacitidine for the first relapsed patients with infant acute lymphoblastic leukemia and MLL gene rearrangement
- Conditions
- Children with first relapsed infant MLL gene rearrangement positive acute lymphoblastic leukemia
- Registration Number
- JPRN-UMIN000029275
- Lead Sponsor
- ational Center for Child Health and Development
- Brief Summary
Primary endpoint of this trial was incidence of dose limiting toxicity (DLT) of the investigational drug azacytidine. No DLT was observed in DL1 for the registered patient. However, at least three patients are required to evaluate the incidence of DLT in DL1; therefore, DLT of azacitidine could not be evaluated in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Not provided
Patients should be excluded if either of the below criteria is met: (1) Patients with uncontrollable infections. (2) Patients with congenital heart disease which require any interventions. (3) Patients with somatic chromosomal abnormalities. (4) Patients with active hemorrhage at study entry. (5) Patients with CNS symptoms at study entry. (6) Patients with other malignant diseases. (7) Patients with isolated extramedullary relapse. (8) Patients with CNS relapse. (9) Patients not eligible for the study entry decided by the primary/co-investigators of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method