drugset / Trial / NCT02112916
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Timeline
- Start
- 2014-10-04
- Primary completion
- 2020-03-31
- Completion
- 2026-09-16
Publications
- Hayashi RJ, Hermiston ML, Wood BL, Teachey DT, Devidas M, Chen Z, Annett RD, Asselin BL, August K, Cho S, Dunsmore KP, Freedman JL, Galardy PJ, Harker-Murray P, Horton TM, Jaju A, Lam A, Messinger YH, Miles RR, Okada M, Patel S, Schafer ES, Schechter T, Shimano KA, Singh N, Steele A, Sulis ML, Vargas SL, Winter SS, Wood C, Zweidler-McKay PA, Loh ML, Hunger SP, Raetz EA, Bollard CM, Allen CE. MRD at the end of induction and EFS in T-cell lymphoblastic lymphoma: Children's Oncology Group trial AALL1231. Blood. 2024 May 16;143(20):2053-2058. doi: 10.1182/blood.2023021184.
- Gossai NP, Devidas M, Chen Z, Wood BL, Zweidler-McKay PA, Rabin KR, Loh ML, Raetz EA, Winick NJ, Burke MJ, Carroll AJ, Esiashvili N, Heerema NA, Carroll WL, Hunger SP, Dunsmore KP, Winter SS, Teachey DT. Central nervous system status is prognostic in T-cell acute lymphoblastic leukemia: a Children's Oncology Group report. Blood. 2023 Apr 13;141(15):1802-1811. doi: 10.1182/blood.2022018653.
- Teachey DT, Devidas M, Wood BL, Chen Z, Hayashi RJ, Hermiston ML, Annett RD, Archer JH, Asselin BL, August KJ, Cho SY, Dunsmore KP, Fisher BT, Freedman JL, Galardy PJ, Harker-Murray P, Horton TM, Jaju AI, Lam A, Messinger YH, Miles RR, Okada M, Patel SI, Schafer ES, Schechter T, Singh N, Steele AC, Sulis ML, Vargas SL, Winter SS, Wood C, Zweidler-McKay P, Bollard CM, Loh ML, Hunger SP, Raetz EA. Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma. J Clin Oncol. 2022 Jul 1;40(19):2106-2118. doi: 10.1200/JCO.21.02678. Epub 2022 Mar 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Ifosfamide | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intravenous |
| Background | Thioguanine | Small molecule | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |