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

NCT04996160 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-04-17

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Tanja Andrea Gruber

    lead OTHER

Principal Investigators

  • Tanja A Gruber, MD · Stanford Universiy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2023-10-16
Completion
2023-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996160 on ClinicalTrials.gov