OncoMatch/Clinical Trials/NCT04996160
Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)
Is NCT04996160 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Palbociclib and Dexamethasone for acute lymphoblastic leukemia, pediatric.
Treatment: Palbociclib · Dexamethasone · Bortezomib · Doxorubicin — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Prior therapy
Must have received: chemotherapy — relapsed or refractory to chemotherapy as defined by ≥ 5% leukemic blasts in the bone marrow or flow cytometry confirmed leukemic blasts in the peripheral blood
relapsed or refractory to chemotherapy as defined by ≥ 5% leukemic blasts in the bone marrow or flow cytometry confirmed leukemic blasts in the peripheral blood
Cannot have received: proteasome inhibitor (bortezomib)
Exception: Subjects that responded but had a subsequent relapse are eligible.
Subjects who have previously received bortezomib or other proteasome inhibitors that did not have a response while receiving the inhibitor are not eligible.
Cannot have received: CDK4/6 inhibitor (palbociclib)
Subjects who have previously received palbociclib or other CDK4/6 inhibitors are not eligible.
Lab requirements
Kidney function
glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine based on age
Liver function
Total bilirubin ≤ 2 x ULN for age, and ALT < 3 x ULN for age, unless elevation is due to leukemic infiltration
Cardiac function
shortening fraction of > 27% or ejection fraction > 45%
Adequate renal function defined as glomerular filtration rate > 60 mL/min/1.73 m2 or serum creatinine based on age ... Adequate hepatic function defined as Total bilirubin ≤ 2 x ULN for age, and ALT < 3 x ULN for age, unless elevation is due to leukemic infiltration ... Adequate cardiac function defined as shortening fraction of > 27% or ejection fraction > 45%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lucile Packard Children's Hospital Stanford · Stanford, California
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