NCT04051996

GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia

Terminated Phase 2 Results posted Last updated 15 October 2021

What this trial tests

Phase 2 trial testing Glasdegib in ACUTE MYELOID LEUKEMIA in 1 participant. Terminated before completion.

Timeline

6 December 2019

Primary endpoint
9 June 2020

9 June 2020

Quick facts

Lead sponsor	Yale University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1
Start date	6 December 2019
Primary completion	9 June 2020
Estimated completion	9 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Glasdegib (glasdegib) — full drug profile →
• Decitabine (decitabine) — full drug profile →

Conditions studied

• ACUTE MYELOID LEUKEMIA — all drugs for ACUTE MYELOID LEUKEMIA →

Sponsor

Yale University

Who can join

18 and older, any sex, with ACUTE MYELOID LEUKEMIA. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DAC5

Serious: 1/1 (100%)

Deaths: 1/1

DAC10

Serious: 0

Deaths: 0

Serious adverse events (2 terms)

Reaction	System	DAC5	DAC10
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Acute Kidney Injury	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Dyspnea, Acute Kidney Injury.

Data from ClinicalTrials.gov NCT04051996 adverse events section.

Sponsor's own description

This multi-center, randomized phase 2 study is designed to evaluate the complete remission (including complete remission with incomplete count recovery) rates of glasdegib in combination with either decitabine on a 5-day or 10-day schedule in patients with newly-diagnosed poor-risk AML who either refuse or are ineligible for intensive therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting multiple signaling pathways: the new approach to acute myeloid leukemia therapy.
   Carter JL, Hege K, Yang J, Kalpage HA, et al · · 2020 · cited 148× · PMID 33335095 · DOI 10.1038/s41392-020-00361-x
2. Hedgehog Pathway Inhibitors as Targeted Cancer Therapy and Strategies to Overcome Drug Resistance.
   Nguyen NM, Cho J. · · 2022 · cited 88× · PMID 35163655 · DOI 10.3390/ijms23031733
3. Hedgehog Pathway Inhibitors: A New Therapeutic Class for the Treatment of Acute Myeloid Leukemia.
   Jamieson C, Martinelli G, Papayannidis C, Cortes JE. · · 2020 · cited 51× · PMID 34661144 · DOI 10.1158/2643-3230.bcd-20-0007
4. Advances in targeted therapy for acute myeloid leukemia.
   Yu J, Jiang PYZ, Sun H, Zhang X, et al · · 2020 · cited 48× · PMID 32477567 · DOI 10.1186/s40364-020-00196-2
5. The Role of Smoothened in Cancer.
   Jeng KS, Sheen IS, Leu CM, Tseng PH, et al · · 2020 · cited 47× · PMID 32962123 · DOI 10.3390/ijms21186863
6. The role of Hedgehog and Notch signaling pathway in cancer.
   Xia R, Xu M, Yang J, Ma X. · · 2022 · cited 39× · PMID 36517618 · DOI 10.1186/s43556-022-00099-8
7. Understanding the Hedgehog Signaling Pathway in Acute Myeloid Leukemia Stem Cells: A Necessary Step toward a Cure.
   Lainez-González D, Serrano-López J, Alonso-Domínguez JM. · · 2021 · cited 20× · PMID 33804919 · DOI 10.3390/biology10040255
8. The hedgehog pathway in hematopoiesis and hematological malignancy.
   Lemos T, Merchant A. · · 2022 · cited 13× · PMID 36091167 · DOI 10.3389/fonc.2022.960943