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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06007911
Phase
PHASE1
Status
Withdrawn

Conditions

  • Refractory AML
  • Relapsed Adult AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Aug 23, 2023
Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level -1
    Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level 0
    This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level 1
    This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Level 2
    This is a regimen of navitoclax, venetoclax, cladribine and cytarabine.
  • Experimental: Cladribine-Low Dose Cytarabine Backbone Dose Maximum Tolerated Dose (MTD)
    The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.
  • Experimental: CLAG-M Backbone Level -1
    Dose level -1 will be considered only if there are dose-limiting toxicities at dose level 0. This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
  • Experimental: CLAG-M Backbone Level 0
    This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and granulocyte colony-stimulating factor (G-CSF).
  • Experimental: CLAG-M Backbone Level 1
    This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
  • Experimental: CLAG-M Backbone Level 2
    This is a regimen of navitoclax, venetoclax, cladribine, cytarabine, mitoxantrone and G-CSF.
  • Experimental: CLAG-M Backbone Maximum Tolerated Dose
    The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a dose-limiting toxicity.

Primary Outcome Measure

Recommended Phase 2 Dose of Navitoclax for the Cladribine-Low Dose Cytarabine Backbone [ Time Frame: Up to three years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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