drugset / Trial / NCT04845035

Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

NCT04845035 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study will combine a standard, pediatric-inspired, chemotherapy regimen with the tyrosine kinase inhibitors (TKIs) Dasatinib and Ponatinib to treat adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. There are two age groups/cohorts: * participants aged 18 to 59 years * participants aged 60 years and older One tyrosine kinase inhibitor (TKI), either Dasatinib or Ponatinib, will be administered in each of the respective chemotherapy cycles. The TKI (either Dasatinib or Ponatinib) administered in a given cycle of chemotherapy will be dictated by the given cycle's standard chemotherapy, in order to minimize overlapping side effects of the chemotherapy and TKI. The dosages of the standard chemotherapy agents, as well as the tyrosine kinase inhibitors (TKIs)--Dasatinib and Ponatinib--have been adjusted for each age group to allow continuous administration of these TKIs.

Timeline

Start
2024-01
Primary completion
2026-01
Completion
2029-01

Outcome

Outcome not reported

Stopped: “The PI plans to revise the study design in a new protocol”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — —
Subject Cytarabine Small molecule — Intrathecal
Subject Daunorubicin Small molecule — —
Subject Dexamethasone Small molecule — —
Subject Doxorubicin Other / unclassified — —
Subject MERCAPTOPURINE ANHYDROUS Small molecule — —
Subject Methotrexate Small molecule — Intrathecal
Subject Pegaspargase Protein / enzyme biologic — —
Subject Ponatinib Small molecule — Oral
Subject Prednisone Other / unclassified — —
Subject Rituximab Monoclonal antibody — —
Subject Thioguanine Small molecule — —
Subject Vincristine Small molecule — —
Subject dasatinib anhydrous Small molecule — Oral