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Clinical Trial Summary

With this research study has following goals - To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated. - To learn more about side effects of palbociclib in combination with chemotherapy; - To learn more about the biological effects of palbociclib on the cells in your body


Clinical Trial Description

Primary objective: To confirm the safety of the previously estimated MTD of 100 mg/m2/daily palbociclib on Days 1 to 5; 11 to 15; and 21 to 30, in combination with chemotherapy, on the basis of observed DLTs for pediatric relapsed ALL patients that do not have Ph+ and Ph like mutations (Cohort 1), and to determine the MTD of palbociclib in combination with chemotherapy and kinase inhibition in pediatric relapsed ALL patients with Ph+ and Ph like subtypes (Cohort 2). Secondary objective: To estimate the overall response rate (ORR) to the combination of palbociclib and chemotherapy in pediatric subjects with relapsed or refractory ALL that does not carry Ph+ or Ph like mutations (Cohort 2). ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia, Pediatric
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Refractory Acute Lymphoblastic Leukemia
  • Relapsed Acute Lymphoblastic Leukemia

NCT number NCT04996160
Study type Interventional
Source Stanford University
Contact Tanja A Gruber
Phone 650-725-4318
Email tagruber@stanford.edu
Status Recruiting
Phase Phase 1
Start date July 9, 2021
Completion date December 2025

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