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

NCT02140242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 721

Last updated 2023-09-15

No results posted yet for this study

Summary

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.

Conditions

  • Leukemia, Myelocytic, Acute

Interventions

DRUG

study part 1 - dose daunorubicin

standard induction dose of daunorubicin 60 mg/m2 on days 3-5

PROCEDURE

induction cycles

single induction cycle versus double induction cycles (only patients with good response after first induction) Allocation is randomized for cytogenetic risk.

Sponsors & Collaborators

  • University Hospital Dresden

    collaborator OTHER

  • Masaryk University

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Christoph Röllig, Prof. Dr. · Medizinische Fakultät der TU Dresden, Medizinische Klinik und Poliklinik I

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-16
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • Czechia
  • Germany

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 NCT02140242 on ClinicalTrials.gov