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A phase 3 trial of Asparaginase, Crisantaspase, Cytarabine, Daunorubicin, Etoposide, Mitoxantrone and Thioguanine in Acute myeloid leukaemia and Leukaemia, run by Children's Oncology Group, active and no longer recruiting.
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome is a phase 3 interventional study registered as NCT02521493 by Children's Oncology Group, with 280 participants planned, started 2015-12-23 and due to reach its primary completion in 2024-06-30. Interventions recorded: Asparaginase, Asparaginase Erwinia chrysanthemi, Cytarabine, Daunorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Thioguanine. Conditions recorded: Acute Myeloid Leukemia, Down Syndrome, Myelodysplastic Syndrome, Myeloid Leukemia Associated With Down Syndrome, Myeloproliferative Neoplasm.
Linked to the drug Crisantaspase because the registry names it among its interventions and Acute myeloid leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
280 enrolled.
95% CI 82 to 93.8; Figures from the ClinicalTrials.gov results section (first posted 2025-06-13), not from a publication · 95% CI 64.8 to 89.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free Survival (EFS)primary | Arm A (Standard Risk) | 114 | 89.37% | - | - | link |
| Arm B (High Risk) | 41 | 80.49% |
Shares Crisantaspase (recombinant Erwinia asparaginase), Mitoxantrone, Daunorubicin, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase) and the tag pipeline.
Shares Mitoxantrone, Daunorubicin, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Cytarabine and the tag pipeline.
Shares Thioguanine, Mitoxantrone, Daunorubicin, Cytarabine and the tag pipeline.
Shares Mitoxantrone, Daunorubicin, Cytarabine, Etoposide and the tag pipeline.
Shares Daunorubicin, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Cytarabine, Children's Oncology Group (COG) and the tag pipeline.
Shares Thioguanine, Daunorubicin, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Cytarabine and the tag pipeline.
Shares Daunorubicin, Cytarabine, Etoposide, Acute myeloid leukaemia and the tag pipeline.
Shares Thioguanine, Daunorubicin, Cytarabine, Etoposide and the tag pipeline.