A Study of BGB-11417 in Participants With Myeloid Malignancies

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeiGene

About this trial

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Eligibility criteria

Qualifiers

AML, nonacute promyelocytic leukemia

MDS

MDS/MPN

Eastern Cooperative Oncology Group performance status of 0 to 2.

Disqualifiers

A diagnosis of acute promyelocytic leukemia.

History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)

Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.

Prior therapy with a B-cell lymphoma-2 inhibitor

Trial design

Treatments tested in this trial

  • BGB-11417
  • Azacitidine
  • Posaconazole
  • BGB-11417
  • BGB-11417

Treatment groups

260 Participants
are divided into 4 treatment groups

Sponsors and collaborators