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

NCT06007911 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-08-13

No results posted yet for this study

Summary

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

Conditions

  • Relapsed Adult AML
  • Refractory AML

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Guru Subramanian Guru Murthy, MD, MS · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-12-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007911 on ClinicalTrials.gov