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Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)

Refractory Acute Lymphoblastic Leukemia Clinical Trial

Official title:
A Phase1 Study at Stanford of Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)

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
Clinical Trial Details
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
View Details
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