JPRN-jRCTs041210015
Recruiting
Phase 3
A phase III clinical trial evaluating efficacy and safety of minimal residual disease-based risk stratification for children with acute myeloid leukemia, incorporating a randomized study of gemtuzumab ozogamicin in combination with post-induction chemotherapy for non-low-risk patients - JPLSG-AML-20
Tomizawa Daisuke0 sites500 target enrollmentMay 10, 2021
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Tomizawa Daisuke
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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