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A phase 3 trial of Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin, Dexamethasone, Doxorubicin, Etoposide, Leucovorin, Mercaptopurine, Methotrexate, Asparaginase, Prednisone, Thioguanine and Vincristine in Acute lymphoblastic leukaemia and Leukaemia, run by National Cancer Institute (NCI), completed.
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations is a phase 3 interventional study registered as NCT02883049 by National Cancer Institute (NCI), with 5949 participants recorded, started 2012-02-29 and reaching its primary completion in 2022-12-31. Interventions recorded: Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Hydrocortisone Sodium Succinate, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Prednisone, Radiation Therapy, Thioguanine, Vincristine Sulfate. Conditions recorded: B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Central Nervous System Leukemia, Testicular Leukemia.
Linked to the drug Clofarabine because the registry names it among its interventions and Acute lymphoblastic 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.
5,949 enrolled.
95% CI 90.7 to 94.3; Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication · 95% CI 90.5 to 94.2
Source95% CI 72.4 to 81.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication · 95% CI 72.8 to 80.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backboneprimary | Non-DS HR B-ALL Arm A | 868 | 92.48% | 1.022 (0.74 to 1.413) | 0.893 | link |
| Non-DS HR B-ALL Arm B | 866 | 92.33% | ||||
| DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)primary | Non-DS VHR B-ALL Control Arm | 335 | 77.11% | 1.019 | 0.556 | link |
| Non-DS VHR B-ALL Exp Arm1 | 488 | 76.75% |
Shares Mercaptopurine, Daunorubicin, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Cytarabine and the tag pipeline.
Shares Thioguanine, Mercaptopurine, Daunorubicin, Cytarabine and the tag pipeline.
Shares Thioguanine, Mercaptopurine, Daunorubicin, Cytarabine and the tag pipeline.
Shares Clofarabine, Mercaptopurine, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Cytarabine and the tag pipeline.
Shares Daunorubicin, Cytarabine, Prednisone, Dexamethasone and the tag pipeline.
Shares Cytarabine, Leucovorin (folinic acid), Methotrexate, Prednisone and the tag pipeline.
Shares Cytarabine, Methotrexate, Prednisone, Dexamethasone and the tag pipeline.
Shares Thioguanine, Daunorubicin, Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Cytarabine and the tag pipeline.