A phase 1/2, open-label study of ponatinib with chemotherapy in paediatric patients With Ph+ ALL
Research type
Research Study
Full 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
IRAS ID
1003358
Contact name
Donna Lancaster
Contact email
Eudract number
2019-002549-39
Clinicaltrials.gov Identifier
Research summary
lay Summary of Results
Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04501614%253Ftab%253Dresults%2FNBTI%2Ft_q6AQ%2FAQ%2F3de0741f-17a6-4e65-b489-819c965bc7b5%2F3%2F78ZutRlMWs&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C3bf4a6e0e09d476fde0f08dd3c8a61ba%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638733287217643352%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=YkH8W3SbRXe1uJEFPu3xDXI0oE%2FLyRUxrWm8pWlNx%2FA%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it: The original dissemination plan could not be followed due the unforeseen impact on the dissemination plan as a result of the early termination of Study Ponatinib-1501. We will follow up with publishing the limited data collected from the study in due course.
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: At the end of the study and after completing data analysis, a summary of the results will be provided to all investigators. They will discuss the results with participants upon request.
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.takeda.%2FNBTI%2Ft_q6AQ%2FAQ%2F3de0741f-17a6-4e65-b489-819c965bc7b5%2F4%2Fougm4WxQA1&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C3bf4a6e0e09d476fde0f08dd3c8a61ba%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638733287217655782%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2PQRaQHyA3P7V8g6yJmAxWqR1conldS%2B1GQEfKLUQAI%3D&reserved=0
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: This was a phase 1 study limited to 11 patients, and we did not have sufficient patients to conduct any meaningful biomarker data or efficacy data.REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/1054
Date of REC Opinion
7 Dec 2020
REC opinion
Further Information Favourable Opinion