A clinical trial of risk-stratification and gemtuzumab ozogamicin combined post-induction chemotherapy for children with AM
- Conditions
- Acute Myeloid LeukemiaD015470
- Registration Number
- JPRN-jRCTs041210015
- Lead Sponsor
- Tomizawa Daisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
(1) Diagnosis of AML
(2) Age 0 to <16 years at diagnosis
(3) ECOG performance status (PS) score or JPLSG Infant Leukemia Committee PS score of 0 to 3; those with PS score 4 is also eligible if that is derived from AML
(4) Newly diagnosed AML without prior therapy for AML; history of steroid, ATRA due to suspicion of APL, or single intrathecal methotrexate due to suspicion of ALL are permitted
(5) Sufficient organ function meeting both laboratory data listed below (should be evaluated =<7 days of trial entry);
Serum T-Bil: <3x of the age-dependent normal range
Serum creatinine: <3x of the age-dependent normal range
(6) Prior consent to participating the JPLSG-CHM-14 study is mandatory
(7) Written informed consent from the legal guardian.
(1) <36 week and 0 day gestational age, if age =<30 days at diagnosis
(2) Patients with following diagnosis
1) RARA-associated fusion gene positive acute promyelocytic leukemia (APL)
2) AML associated with Down Syndrome (ML-DS)
3) Secondary AML (history of congenital bone marrow failure syndrome, myelodysplastic syndrome, and/or prior chemotherapy)
4) Ambiguous lineage acute leukemia (ALAL). ALAL with AML-specific genetic abnormalities are eligible
5) Myeloid sarcoma
(3) Uncontrollable infections (including active tuberclosis, HBV, and/or HCV)
(4) Pregnant or lactating females
(5) History of congenital or acquired immunodeficiencies
(6) Presence of organ dysfunction interfering trial therapy
a) Uncontrollable heart failure (presence of heart anomly itself is not a exclusion criteria)
b) Uncontrollable renal failure
c) Respiratory failure requiring mechanical ventilation
d) >= grade 3 intracranial hemorrhage (CTCAE ver 5.0)
(7) Presence of other malignant neoplasms
(8) Other inappropriate status judged by physician
(9) Patients considered as inappropriate to participate in the trial judged by the primary investigators and co-investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year disease-free survival (DFS) rate of the non-LR patients (IR and HR)
- Secondary Outcome Measures
Name Time Method CR rate<br>Overall survival (OS)<br>Event-free survival (EFS)<br>Cumulative incidence of relapse (CIR)<br>Non-relapse mortality (NRM)<br>Incidence of grade 3 or higher aderse events defined by CTCAE ver.5.0<br>Evaluation of the patients' Quality of Life (QOL) obtained from the patients' family questionnaire<br>OS, EFS, CIR, and NRM according to the MRD levels at TP1<br>Rate of transplant-related complications and mortality at day 100 and at one year<br>Incidence of invasive fungal infections according to the GO randomization<br>Incidence of invasive fungal infections according to the use of prophylactic anti-fungal agents<br>Incidence of bacterial infections according to the use of prophylactic antibiotics