Venetoclax and Lintuzumab-Ac225 in AML Patients

Part of paid clinical trials in Los Angeles, California.

Sponsor
Actinium Pharmaceuticals
Study ID
NCT03867682
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Lintuzumab-Ac225 — BIOLOGICAL
    In the Phase I, patients will be enrolled into the following dose escalation cohorts: 0.50 μCi/kg, 1.0 μCi/kg, and 1.5 μCi/kg. If the 0.50 μCi/kg dose is determined to exceed the MTD, a 0.25 μCi/kg dose will be explored.
  • Venetoclax — DRUG
    400 mg daily will be taken orally on Days 1-21 of a 28-day cycle. There will be a ramp up of venetoclax dosing in the first cycle, with 100 mg administered on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and Day 4 and later. Patients on antifungal azoles should receive one-half these doses, up to a maximum of 200 mg of venetoclax.
  • Spironolactone — DRUG
    25 mg by mouth daily, administered on Cycle 1 Day 15 and continued for 12 months after the subject's last treatment with lintuzumab-Ac225.

Study Details

The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. (Phase 1 portion) 2. To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies. (Phase 2 portion)

Key Dates

Start date
Jan 15, 2020
Status verified
Aug 2023
Primary completion
Nov 30, 2023
Completion
Jun 30, 2024

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I and Phase II
    Lintuzumab-Ac225 administered on Day 5 of each cycle for four cycles (unless in the 0.5 μCi/kg or 0.25 μCi/kg cohorts, where there is a potential for an additional four cycles, pending PI and Medical Monitor review). Venetoclax taken on Days 1-21 of each cycle for up to 12 cycles. Each cycle is 28 days, with a potential to expand to 42 days to allow for full hematologic recovery.

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225 [ Time Frame: Cycle 1, up to 48 days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of CaliforniaLos AngelesCalifornia90095-
University of LouisvilleLouisvilleKentucky40202-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Weill Cornell MedicineNew YorkNew York10021-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California· Los Angeles, CAUniversity of Louisville· Louisville, KYOchsner Clinic Foundation· New Orleans, LAWeill Cornell Medicine· New York, NYFred Hutchinson Cancer Research Center· Seattle, WA

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