CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 32 enrolled
Drug / intervention
Decitabine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03132454
NCT03132454Phase 1Active

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

M.D. Anderson Cancer Center·interventional·Posted Apr 27, 2017·Updated Apr 15, 2026

In Brief

A Phase 1 clinical trial evaluating Decitabine, Dexamethasone, and 2 other interventions for Recurrent Acute Lymphoblastic Leukemia and 3 related conditions. Active but no longer recruiting, targeting 32 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 1Active
20182019202020212022202320242025202620272028
First PostedApr 27, 2017
Enrollment StartJul 25, 2017
Primary CompletionDec 31, 2027
TodayJul 1, 2026
Enrollment to primary: 10.4 yearsPosted 9.2 years agoPrimary completion in 1.5 years

Interventions

Decitabinedrug

Given IV

Dexamethasonedrug

Given IV or PO

Palbociclibdrug

Given PO

Sorafenibdrug

Given PO