Study Title
A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation
Protocol ID
Ponatinib-1501 /AALL1922
Disease (Sub Disease)
Leukaemia (ALL)
Diagnosis Stage
Relapse/ refractory
Location
QLD, VIC, WA
Sponsor
Takeda
Links
Trial Status
Open
Sites
Royal Children's Hospital
Perth Children's Hospital
Queensland Children's Hospital
Perth Children's Hospital
Queensland Children's Hospital
Study Type
Treatment
Phase
Phase 1/2
Age Eligibility
1 Year to 21 Years
International registry ID's
NCT04501614
| Study Title | A Pivotal Phase 1/2 Single-Arm Open-label Study to Evaluate the Safety and Efficacy of Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy or Who Have the T315I Mutation |
|---|---|
| Protocol ID | Ponatinib-1501 /AALL1922 |
| Disease (Sub Disease) | Leukaemia (ALL) |
| Diagnosis Stage | Relapse/ refractory |
| Location | QLD / VIC / WA |
| Sponsor | Takeda |
| Links | https://clinicaltrials.gov/ct2/show/NCT04501614 |
| Trial Status | Open |
| Trial Open Date | 21/02/2021 |
| Sites | Royal Children's Hospital / Perth Children's Hospital/ Queensland Children's Hospital |
| Study Type | Treatment |
| Phase | Phase 1/2 |
| Age Eligibility | 1 Year to 21 Years |
| International registry ID's | NCT04501614 |