Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia

Summary

This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.

Timeline

Start

2017-11-29

Primary completion

2027-11-30

Completion

2027-11-30

Publications

• Short NJ, Kantarjian H, Furudate K, Jain N, Ravandi F, Karrar O, Loghavi S, Nasr L, Haddad FG, Senapati J, Garris R, Takahashi K, Jabbour E. Molecular characterization and predictors of relapse in patients with Ph + ALL after frontline ponatinib and blinatumomab. J Hematol Oncol. 2025 May 14;18(1):55. doi: 10.1186/s13045-025-01709-y.
• Kantarjian H, Short NJ, Haddad FG, Jain N, Huang X, Montalban-Bravo G, Kanagal-Shamanna R, Kadia TM, Daver N, Chien K, Alvarado Y, Garcia-Manero G, Issa GC, Garris R, Nasnas C, Nasr L, Ravandi F, Jabbour E. Results of the Simultaneous Combination of Ponatinib and Blinatumomab in Philadelphia Chromosome-Positive ALL. J Clin Oncol. 2024 Dec 20;42(36):4246-4251. doi: 10.1200/JCO.24.00272. Epub 2024 Jul 19.
• Jabbour E, Short NJ, Jain N, Huang X, Montalban-Bravo G, Banerjee P, Rezvani K, Jiang X, Kim KH, Kanagal-Shamanna R, Khoury JD, Patel K, Kadia TM, Daver N, Chien K, Alvarado Y, Garcia-Manero G, Issa GC, Haddad FG, Kwari M, Thankachan J, Delumpa R, Macaron W, Garris R, Konopleva M, Ravandi F, Kantarjian H. Ponatinib and blinatumomab for Philadelphia chromosome-positive acute lymphoblastic leukaemia: a US, single-centre, single-arm, phase 2 trial. Lancet Haematol. 2023 Jan;10(1):e24-e34. doi: 10.1016/S2352-3026(22)00319-2. Epub 2022 Nov 16.

Drugs

Indications