Health Trials

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Ulm

About this trial

A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

Eligibility criteria

Qualifiers

Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC).

Age ≥ 18 and ≤ 75 years.

Patients considered eligible for intensive chemotherapy.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Venetoclax
  • Placebo
  • Standard chemotherapy
  • Allogeneic stem cell transplantation

Treatment groups

650 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Ulm

Lead sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborator

Source ClinicalTrials.gov