NCT06007911

Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase I study designed to evaluate the safety of venetoclax-navitoclax with cladribine-based salvage therapy.

Detailed description

The primary objective of the study is to determine a maximum-tolerated dose (MTD) combination of venetoclax-navitoclax with cladribine-based salvage therapy. Subjects will be entered sequentially to each dose level. For each dose level, if none of the first three subjects at that level experiences a dose-limiting toxicity (DLT), new subjects may be entered at the next higher dose level. If one of three subjects experience a DLT, up to three more subjects are to be treated at that same dose level. If none of the additional three subjects at that dose level experiences a DLT, new subjects may be entered at the next higher dose level. However, if one or more of the additional three subjects experience a DLT, then no further subjects are to be started at that dose level and either de-escalate one level or if the preceding dose is already completed then that dose is the MTD. The MTD will be defined as the highest dose level at which none of the first three treated subjects, or no more than one of the first six treated subjects, experiences a DLT.

Conditions

• Relapsed Adult AML
• Refractory AML

Interventions

Type	Name	Description
DRUG	Navitoclax Dose Level -1	25 mg by mouth on days 1-7.
DRUG	Navitoclax Dose Level 0	50 mg by mouth on days 1-10.
DRUG	Navitoclax Dose Level 1	75 mg by mouth on days 1-10.
DRUG	Navitoclax Dose Level 2	100 mg by mouth on days 1-10.
DRUG	Venetoclax Dose Level -1	400 mg by mouth on days 1-7.
DRUG	Venetoclax Dose Levels 0 to 2	400 mg by mouth on days 1-14.
DRUG	Cladribine	5 mg/m\^2 intravenously days 1-5.
DRUG	Cytarabine (Cladribine Low Dose Cytarabine Backbone)	20 mg/m\^2 subcutaneous days 1-10.
DRUG	Cytarabine (CLAG-M Backbone)	1.5 g/m\^2 intravenously days 1-5.
DRUG	Mitoxantrone	10 mg/m\^2 intravenously days 1-3.
DRUG	Granulocyte Colony-Stimulating Factor	300 mcg subcutaneously days 1-5.

Timeline

• Start date: 2024-08-31
• Primary completion: 2025-12-01
• Completion: 2027-04-01
• First posted: 2023-08-23
• Last updated: 2024-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study