OncoMatch/Clinical Trials/NCT03286634

ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Is NCT03286634 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for down syndrome.

Phase 2RecruitingNational Hospital Organization Nagoya Medical CenterNCT03286634Data as of May 2026

Treatment: Daunorubicin · Prednisolone · Vincristine · Epirubicin · E-coli L-asparaginase · 6-Mercaptopurine · Methotrexate · Hydrocortisone · Cytarabine · Cyclophosphamide — To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Excluded: BCR fusion

Philadelphia positive ALL

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: cytotoxic chemotherapy

Exception: treatment for TAM or short term steroid (< 7 days of duration within last 1 month prior to treatment start)

Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study.

Cannot have received: radiation therapy

Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy.

Lab requirements

Kidney function

Renal dysfunction with creatinine >2x upper limit of normal (ULN) [excluded]. Patients whose creatinine has improved to <2x ULN before treatment commencement can enrol subject to discretion of site PI.

Liver function

Liver dysfunction with direct bilirubin > 5x ULN [excluded]

Cardiac function

History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years [excluded]

Renal dysfunction with creatinine >2x upper limit of normal (ULN). Liver dysfunction with direct bilirubin > 5x ULN. History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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