Who is sponsoring NCT04493099?

NCT04493099 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT04493099?

Interventions in NCT04493099: Alvocidib Hydrochloride, Decitabine, Venetoclax.

What condition does NCT04493099 study?

NCT04493099 studies Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia.

Is NCT04493099 still recruiting?

NCT04493099 is currently withdrawn. Last updated 9 November 2020.

Last reviewed 2020-11-09 · How we verify

NCT04493099

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1/2 Study of Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML

Withdrawn Phase 1/Phase 2 Last updated 9 November 2020

What this trial tests

Phase 1/Phase 2 trial testing Alvocidib Hydrochloride in Recurrent Acute Myeloid Leukemia. Withdrawn.

Timeline

1 October 2020

Primary endpoint
12 October 2020

12 October 2020

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1/Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 October 2020
Primary completion	12 October 2020
Estimated completion	12 October 2020
Sites	1 location across United States

Drugs / interventions tested

Alvocidib Hydrochloride — full drug profile →
Decitabine (decitabine) — full drug profile →
Venetoclax (venetoclax) — full drug profile →

Conditions studied

Recurrent Acute Myeloid Leukemia — all drugs for Recurrent Acute Myeloid Leukemia →
Refractory Acute Myeloid Leukemia — all drugs for Refractory Acute Myeloid Leukemia →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Recurrent Acute Myeloid Leukemia or Refractory Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Overall incidence and severity of all adverse events (Phase I)
Time frame: Up to 6 years
Measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall response rate (ORR) (Phase II)
Time frame: Up to 6 years
Will estimate the response rate for the combination treatment, along with the 95% credible interval.

Sponsor's own description

This phase I/II trial investigates the side effects and best dose of alvocidib when given together with decitabine and venetoclax and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), has not responded to previous treatment (refractory), or as frontline treatment for patients unable to receive other therapies (unfit). Alvocidib, decitabine, and venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Recurrent Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT06871410 — Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT07263906 — Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia · Phase 1 · recruiting
NCT07025564 — MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06928662 — Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant · Phase 1, PHASE2 · recruiting
NCT06484062 — Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute M · Phase 1 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04493099 (US National Library of Medicine, public domain)
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: 9 November 2020

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/NCT04493099.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing