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ACTIVE NOT RECRUITING
NCT03132454
PHASE1

Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of palbociclib when given alone and in combination with sorafenib, decitabine, or dexamethasone in treating patients with leukemia that has come back (recurrent) or that does not respond to previous treatment (refractory). Palbociclib, sorafenib, and decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib alone and in combination with sorafenib, decitabine, or dexamethasone may work better in treating patients with recurrent or refractory leukemia.

Official title: Phase I Study of Palbociclib Alone and in Combination in Patients With Relapsed and Refractory Leukemias

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2017-07-25

Completion Date

2027-12-31

Last Updated

2025-11-03

Healthy Volunteers

No

Interventions

DRUG

Decitabine

Given IV

DRUG

Dexamethasone

Given IV or PO

DRUG

Palbociclib

Given PO

DRUG

Sorafenib

Given PO

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States