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NCT03132454
Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia
Phase 1 trial testing Decitabine in Recurrent Acute Lymphoblastic Leukemia in 32 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 25 July 2017 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Decitabine (decitabine) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Palbociclib (Palbociclib) — full drug profile →
- Sorafenib (SORAFENIB) — full drug profile →
Conditions studied
- Recurrent Acute Lymphoblastic Leukemia — all drugs for Recurrent Acute Lymphoblastic Leukemia →
- Recurrent Acute Myeloid Leukemia — all drugs for Recurrent Acute Myeloid Leukemia →
- Refractory Acute Lymphoblastic Leukemia — all drugs for Refractory Acute Lymphoblastic Leukemia →
- Refractory Acute Myeloid Leukemia — all drugs for Refractory Acute Myeloid Leukemia →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
15 and older, any sex, with Recurrent Acute Lymphoblastic Leukemia or Recurrent Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495 -
CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought.
Klein ME, Kovatcheva M, Davis LE, Tap WD, et al · · 2018 · cited 308× · PMID 29731395 · DOI 10.1016/j.ccell.2018.03.023 -
A review of FLT3 inhibitors in acute myeloid leukemia.
Zhao JC, Agarwal S, Ahmad H, Amin K, et al · · 2022 · cited 137× · PMID 34774343 · DOI 10.1016/j.blre.2021.100905 -
<i>FLT3</i> Mutations in Acute Myeloid Leukemia: Key Concepts and Emerging Controversies.
Kennedy VE, Smith CC. · · 2020 · cited 132× · PMID 33425766 · DOI 10.3389/fonc.2020.612880 -
Development of Chemotherapy with Cell-Cycle Inhibitors for Adult and Pediatric Cancer Therapy.
Mills CC, Kolb EA, Sampson VB. · · 2018 · cited 110× · PMID 29311160 · DOI 10.1158/0008-5472.can-17-2782 -
Novel therapy in Acute myeloid leukemia (AML): moving toward targeted approaches.
Winer ES, Stone RM. · · 2019 · cited 92× · PMID 31321011 · DOI 10.1177/2040620719860645 -
Emerging treatment paradigms with FLT3 inhibitors in acute myeloid leukemia.
Short NJ, Kantarjian H, Ravandi F, Daver N. · · 2019 · cited 86× · PMID 30800259 · DOI 10.1177/2040620719827310 -
The New Therapeutic Strategies in Pediatric T-Cell Acute Lymphoblastic Leukemia.
Lato MW, Przysucha A, Grosman S, Zawitkowska J, et al · · 2021 · cited 59× · PMID 33925883 · DOI 10.3390/ijms22094502
Verify or expand the search:
- PubMed search for NCT03132454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03132454 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03132454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing