NCT02140242: DaunoDouble

Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML

Completed Phase 3 Last updated 15 September 2023

What this trial tests

Phase 3 trial testing study part 1 - dose daunorubicin in Leukemia, Myelocytic, Acute in 721 participants. Completed in 25 April 2022.

Timeline

16 April 2014

Primary endpoint
25 April 2022

25 April 2022

Quick facts

Lead sponsor	Technische Universität Dresden
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	721
Start date	16 April 2014
Primary completion	25 April 2022
Estimated completion	25 April 2022
Sites	38 locations across Germany, Czechia

Drugs / interventions tested

• study part 1 - dose daunorubicin — full drug profile →
• induction cycles

Conditions studied

• Leukemia, Myelocytic, Acute — all drugs for Leukemia, Myelocytic, Acute →

Sponsor

Technische Universität Dresden — full company profile →

Who can join

Adults 18 to 65, any sex, with Leukemia, Myelocytic, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed trial will address two clinically important questions for younger patients with newly diagnosed acute myeloid leukemia (AML): the optimal dose of daunorubicin in induction therapy and the necessity of a second induction cycle in patients with a good response after the first induction. The primary endpoint is the rate of good responders. Secondary outcomes will be relapse-free survival, overall survival and minimal residual disease kinetics. Patients will be recruited in about 40 treatment centers of the Study Alliance Leukemia study group over a period of 40 months. The results will be of great clinical relevance: First, the study could facilitate the establishment or confirmation of the optimal daunorubicin dose.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune Checkpoint Blockade for Aspergillosis and Mucormycosis Coinfection.
   Banck JC, Mueller N, Mellinghoff SC, Thelen M, et al · · 2021 · cited 22× · PMID 33604513 · DOI 10.1097/hs9.0000000000000530
2. Randomized Comparison of Cardiotoxicity With 60 Versus 90 mg Daunorubicin in AML Induction Therapy.
   Dendorfer SM, Schmidt-Brücken K, Kramer M, Steffen B, et al · · 2026 · cited 1× · PMID 41492073 · DOI 10.1002/ajh.70160