RecruitingPhase 1NCT04996160

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

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


Sponsor

Tanja Andrea Gruber

Enrollment

22 participants

Start Date

Jul 9, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study (RELPALL2) tests the combination of palbociclib (a drug that pauses cancer cell growth) with chemotherapy in children and young adults (under 25) with acute lymphoblastic leukemia (ALL) — a type of blood cancer — that has returned or stopped responding to prior treatments. **You may be eligible if...** - You are under 25 years old with ALL that has relapsed or is refractory (not responding to treatment) - You have confirmed leukemia blasts in bone marrow or blood - Your general functional status is adequate (Karnofsky/Lansky score >50) - Your heart, liver, kidney, and lung function meet the required thresholds - You have recovered from the effects of prior therapy **You may NOT be eligible if...** - You have isolated CNS or testicular leukemia only (without bone marrow involvement) - You have previously received palbociclib or other CDK4/6 inhibitors without benefit - You have active HIV or active hepatitis B or C - You are pregnant or breastfeeding - You have an active uncontrolled infection - Your cumulative anthracycline dose is already very high (above 400 mg/m²) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

Oral

DRUGDexamethasone

8 mg/m2/day divided BID, PO, NG, or IV

DRUGBortezomib

1.3 mg/m2/dose, IV (preferred) or SC

DRUGDoxorubicin

25 mg/m2/dose IV


Locations(1)

Lucile Packard Children's Hospital Stanford

Stanford, California, United States

View Full Details on ClinicalTrials.gov

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NCT04996160


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