drugset / Trial / NCT03589326
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.
Timeline
- Start
- 2018-10-04
- Primary completion
- 2022-08-12
- Completion
- 2027-07-31
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imatinib | Small molecule | 600 mg | Oral |
| Subject | Ponatinib | Small molecule | 30 mg | Oral |
| Background | Cytarabine | Small molecule | 250 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Methotrexate | Small molecule | 250 mg/m2 | Intravenous |
| Background | Methotrexate | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 50 mg | — |
| Background | Prednisone | Other / unclassified | 100 mg | — |
| Background | Prednisone | Other / unclassified | 200 mg | — |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |