RightFit
RecruitingPhase 1 / Phase 2

A Study of BGB-11417 in Participants With Myeloid Malignancies

A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BGB-11417 alone and with azacitidine in people with certain blood and bone marrow cancers: AML, MDS, or MDS/MPN. It checks safety, side effects, and how well treatment may work, and aims to find a dose for the next stage of testing.

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) .

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS/myeloproliferative neoplasm (MDS/MPN). These are blood and bone marrow cancers.
  • Be able to care for yourself and be out of bed or a chair for more than half of your waking hours, even if you cannot work.
  • Have a kidney filtering rate of at least 50 mL/min. A rate of 30–49 mL/min may be allowed in the AML group considered less fit for treatment.
  • Have liver function that meets the study's requirements.
  • Be expected to live more than 12 weeks.
  • Be able to follow the study's requirements.

Who can't join

  • Have acute promyelocytic leukemia, a type of AML.
  • Have had another cancer, unless it was MDS or MDS/MPN that became AML, or it was treated with the goal of a full cure and has not returned within the past 2 years.
  • Have had an MPN, a blood cancer such as myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia.
  • Have AML with a gene change called BCR-ABL1.
  • Have received a BCL-2 inhibitor, a drug that blocks a protein that helps cancer cells survive.
  • Have leukemia known to affect the brain or spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria: * AML, nonacute promyelocytic leukemia * MDS * MDS/MPN 2. Eastern Cooperative Oncology Group performance status of 0 to 2. 3. Adequate organ function defined as: * Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort) * Adequate liver function 4. Life expectancy of \> 12 weeks. 5. Ability to comply with the requirements of the study. Key Exclusion Criteria: 1. A diagnosis of acute promyelocytic leukemia. 2. 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) 3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation. 4. Prior therapy with a B-cell lymphoma-2 inhibitor 5. Known central nervous system involvement by leukemia. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study sites (5)

CA

FL

PA

TX

WI