Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-02 @ 9:48 AM
Study NCT ID:
NCT05455294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms
Sponsor:
Jacqueline Garcia, MD
Organization:
Study Overview
Official Title:
A Phase 1 Study of Triplet Therapy With Navitoclax, Venetoclax, and Decitabine for High-risk Myeloid Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies.
The names of the drugs involved in this study are:
* Venetoclax
* Decitabine
* Navitoclax
The names of the drugs involved in this study are:
* Venetoclax
* Decitabine
* Navitoclax
Detailed Description:
This is a phase 1 study to determine the safety, dosing schedule and recommended phase 2 dose of a triplet therapy with navitoclax, venetoclax, and decitabine for patients with the four high-risk myeloid malignancy subgroups of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MDS/MPN) and myelofibrosis accelerated phase (MF-AP).
The U.S. Food and Drug Administration (FDA) has not approved the combination of venetoclax, navitoclax, and decitabine navitoclax as a treatment for any disease.The FDA has approved the combination of venetoclax and decitabine for acute myeloid leukemia (AML) and decitabine given alone is approved for myelodysplastic syndrome (MDS).
The research study procedures include screening for eligibility, study treatments, and blood tests and bone marrow biopsies to assess response to treatment.
Participants will receive the study treatment regimen as long as it is effective.
It is expected that about 36 people will take part in this research study.
AbbVie, a pharmaceutical company, is supporting this research study by providing funding and the study drugs navitoclax and venetoclax.
The U.S. Food and Drug Administration (FDA) has not approved the combination of venetoclax, navitoclax, and decitabine navitoclax as a treatment for any disease.The FDA has approved the combination of venetoclax and decitabine for acute myeloid leukemia (AML) and decitabine given alone is approved for myelodysplastic syndrome (MDS).
The research study procedures include screening for eligibility, study treatments, and blood tests and bone marrow biopsies to assess response to treatment.
Participants will receive the study treatment regimen as long as it is effective.
It is expected that about 36 people will take part in this research study.
AbbVie, a pharmaceutical company, is supporting this research study by providing funding and the study drugs navitoclax and venetoclax.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: