{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"NCT03589326","nct_id":"NCT03589326","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03589326. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\\<60 years \\[yrs\\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\\^2 as 2-hour IV infusion (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\\^2 (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.","label":"Cohort A: Ponatinib 30 milligram (mg)","type":"EXPERIMENTAL"},{"description":"Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\\^2 every 12 hours as a 2-hour-IV infusion (\\<60 yrs) and 250 mg/m\\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\\^2 (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.","label":"Cohort B: Imatinib 600 mg","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-07-31","type":"ESTIMATED"},"conditions":["Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)"],"enrollment":{"count":245,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ponatinib","otherNames":["Iclusig"],"type":"DRUG"},{"name":"Imatinib","otherNames":["Gleevec"],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Cytarabine","otherNames":[],"type":"DRUG"},{"name":"Methotrexate","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"}],"last_update":"2025-11-26","lead_sponsor":"Takeda","official_title":"A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2022-08-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Minimal Residual Disease (MRD)-Negative Complete Remission (CR) at The End of Induction Phase","timeFrame":"From Cycle 1 through Cycle 3 (approximately 3 months) (Cycle length = 28 days)"}],"references":[{"citation":"Ashaye A, Shi L, Aldoss I, Montesinos P, Vachhani P, Rocha V, Papayannidis C, Leonard JT, Baer MR, Ribera JM, McCloskey J, Wang J, Rane D, Guo S. Quality-Adjusted Time Without Symptoms of Disease or Toxicity (Q-TWiST) in Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Comparison of Ponatinib Versus Imatinib. Cancer Med. 2025 Apr;14(7):e70780. doi: 10.1002/cam4.70780.","pmid":"40165400","type":"DERIVED"},{"citation":"Hanley MJ, Larson TR, Diderichsen PM, Largajolli A, Hui K, Srimani J, Wang B, Vorog A, Gupta N. Population Pharmacokinetic and Exposure-Response Analyses for Ponatinib in the Phase 3 PhALLCON Study. Clin Transl Sci. 2025 Mar;18(3):e70175. doi: 10.1111/cts.70175.","pmid":"40025846","type":"DERIVED"},{"citation":"Jabbour E, Kantarjian HM, Aldoss I, Montesinos P, Leonard JT, Gomez-Almaguer D, Baer MR, Gambacorti-Passerini C, McCloskey J, Minami Y, Papayannidis C, Rocha V, Rousselot P, Vachhani P, Wang ES, Wang B, Hennessy M, Vorog A, Patel N, Yeh T, Ribera JM. Ponatinib vs Imatinib in Frontline Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2024 Jun 4;331(21):1814-1823. doi: 10.1001/jama.2024.4783.","pmid":"38722621","type":"DERIVED"}],"start_date":{"date":"2018-10-04","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia","url":"https://clinicaltrials.gov/study/NCT03589326"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03589326"}