Study on Crenolanib with Chemotherapy vs. Chemotherapy Alone for Treating Relapsed or Refractory FLT3 Mutated Acute Myeloid Leukemia (AML)

Sponsor: Arog Pharmaceuticals, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03250338

Provider View

This clinical trial is comparing the effectiveness of a new drug, crenolanib, combined with chemotherapy, against chemotherapy alone in patients with relapsed or refractory Acute Myeloid Leukemia (AML) that has a specific FLT3 mutation.

Patient Parameters

Program Overview

The study aims to determine if adding crenolanib to chemotherapy can improve treatment outcomes for patients with relapsed or refractory Acute Myeloid Leukemia (AML) that has a specific FLT3 mutation. Participants will receive either crenolanib with chemotherapy or a placebo with chemotherapy, and the study will evaluate the effectiveness of these treatments at various stages, including after initial chemotherapy, after bone marrow transplantation, and as ongoing maintenance therapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Acute Myeloid Leukemia (AML) based on specific medical guidelines.
  • Have a specific genetic mutation known as FLT3-ITD or D835.
  • The cancer must have returned or not responded to initial or second-line treatments.
  • Be between 18 and 75 years old.
  • Have adequate liver function.
  • Have adequate kidney function.
  • Be in relatively good overall health, with a performance status score of 3 or lower, indicating some ability to carry out daily activities.

Exclusion Criteria

  • Have active leukemia in the central nervous system (CNS).
  • Have severe liver disease.
  • Have an active infection with hepatitis B or C.
  • Have received any anti-leukemia treatment within 14 days before starting the study, except for certain medications like hydroxyurea for symptom relief.
  • Have previously been treated with crenolanib or participated in a crenolanib clinical trial.

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