Who is sponsoring NCT03867682?

NCT03867682 is sponsored by Actinium Pharmaceuticals.

What condition does NCT03867682 study?

NCT03867682 studies Acute Myeloid Leukemia, Relapsed Adult AML.

What drugs are being tested in NCT03867682?

Interventions: Lintuzumab-Ac225, Venetoclax, Spironolactone.

What is the status of NCT03867682?

NCT03867682 is currently UNKNOWN.

Last reviewed 2023-08-02 · How we verify

A Phase I/II Study of Venetoclax and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML

NCT03867682 Phase 1/Phase 2 UNKNOWN

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)

Details

Lead sponsor	Actinium Pharmaceuticals
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	38
Start date	2020-01-15
Completion	2024-06

Conditions

Acute Myeloid Leukemia
Relapsed Adult AML

Interventions

Lintuzumab-Ac225
Venetoclax
Spironolactone

Primary outcomes

Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225 — Cycle 1, up to 48 days
To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapse/refractory AML.
Phase II: Overall Response (CR + CRh + CRi) — Up to 6 months
To assess the percentage of patients with CR, CRh, CRi or Overall Response (CR + CRh + CRi), up to 6 months after the start of treatment without receiving other AML therapies.

Countries

United States