Completed PHASE1 INTERVENTIONAL NCT00004871

Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase I, Dose De-Escalation to Minimal Effective Pharmacologic Dose Trial of Sodium Phenylbutyrate (PB, NSC 657802) in Combination With 5-Azacytidine (5-AZA, NSC 102816) in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

Sponsor: National Cancer Institute (NCI)

Conditions Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Interventions azacitidine sodium phenylbutyrate

Updated 5 times since 2017 Last updated: Mar 9, 2010 Started: May 31, 2000

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00004871, this PHASE1 trial focuses on Leukemia and Myelodysplastic Syndromes and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 5 times since 2000, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

May 2000

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Data source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Baltimore, United States