NCT04996160

Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia

A Phase I Study at Stanford of Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Tanja Andrea Gruber · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Acute Lymphoblastic Leukemia, Pediatric
• Relapsed Acute Lymphoblastic Leukemia
• Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Palbociclib	Oral
DRUG	Dexamethasone	8 mg/m2/day divided BID, PO, NG, or IV
DRUG	Bortezomib	1.3 mg/m2/dose, IV (preferred) or SC
DRUG	Doxorubicin	25 mg/m2/dose IV

Timeline

• Start date: 2021-07-09
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2021-08-09
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study