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A Study of BGB-11417 in Participants With Myeloid Malignancies

StatusRecruiting
PhasePhase 1/2
Started2021-05-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Feb 8, 2028 → Aug 31, 2028
See other at-risk trials from BeOne Medicines

Amendment history

2026-09-10
Study Status, Contacts/Locations v40
Primary completion pushed: 2028-02-08 → 2028-08-31
Completion pushed: 2028-02-08 → 2028-08-31
Study sites46→47
2026-07-10
Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations, IPDSharing v39
Sponsor changed: BeiGene → BeOne Medicines+8 characters
WasBeiGene
NowBeOne Medicines
Study description+209 characters
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study sitesdetails revised at 1 of 46 sites
2026-04-21
Study Status, Contacts/Locations v38
Study sites46 entries, revised
Nanfang Hospital of, Southern Medical University
2026-04-13
2 amendments v36-v37
2 re-verifications since 2026-03-03, no change to tracked fields
2026-02-19
Study Status, Contacts/Locations v35
Study sitesdetails revised at 1 of 46 sites
Show 34 earlier versions
2026-02-05
2 amendments v33-v34
2 re-verifications since 2026-01-23, no change to tracked fields
2026-01-13
Study Status, Contacts/Locations v32
Study sites45→46
2025-11-10
Study Status, Contacts/Locations v31
Study sites46→45
2025-10-22
Study Identification, Study Status, Contacts/Locations v30
Study sites49→46
2025-09-19
2 amendments v28-v29
2 re-verifications since 2025-09-11, no change to tracked fields
2025-08-28
Study Status, Contacts/Locations v27
Study sitesdetails revised at 11 of 49 sites
2025-08-05
Study Status v26
Re-verified, no change to tracked fields
2025-07-11
Study Status, Contacts/Locations v25
Study sitesdetails revised at 2 of 49 sites
2025-06-20
3 amendments v22-v24
3 re-verifications since 2025-05-07, no change to tracked fields
2025-04-30
Study Status, Contacts/Locations v21
Study sites51→49
2025-04-11
Study Status, Contacts/Locations v20
Study sites51 entries, revised
Universitaetsklinikum Ulm, Innere Medizin Iii
2025-02-14
Study Status, Contacts/Locations, IPDSharing v19
Study sites52→51
2025-01-28
Study Identification, Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 52 sites
2024-12-04
Study Status, Contacts/Locations v17
Study sites42→52
2024-10-25
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v16
Primary completion date2023-12→2028-02-08
Completion date2025-08→2028-02-08
Study sites41→42
Eligibility criteria+104 characters
[...] sion Criteria: A diagnosis of acute promyelocytic leukemia. PriorHistory 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, except for curatively treated localized skin cancer, superficial bladder cancer, carcinom [...] ix or breast, or localized Gleason score ≤ 6 prostate cancer.) Antecedent MPN including myelofibrosis, essential thrombocy [...] nslocation. Prior therapy with a B-cell lymphoma-2 inhibitor or azacitidine exc [...] [...]
Secondary endpoints32 to 31 entries
Parts 1 And 2 AML Cohort: Complete remission (CR) + Morphologic CR PlusWith Partial Hematologic Recovery (CRh Rate) Parts 1 And 2: Terminal Half-life (t1/2) Of Azacitidine When Coadministered With BGB-11417 Parts 1 And 2: Apparent Total Clearance Of DrugAzacitidine From Plasma After Oral Administration (CL/F) Of Azacitidine When Coadministered With BGB-11417 Part 3: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing TEAEs Part 3: Complete Response Rate Part 3 AML Cohort: Event-free Survival (EFS) Part 3 AML Cohort: Overall Survival (OS) Part 3 AML Cohort: N [...]
Primary endpoints9 entries, revised
Part 1 And 2: Number Of Participants Receiving BGB-11417 In Combination With Azacitidine Experiencing Treatment-emergent Adverse Events (TEAEs) Part [...] ) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole Part 3 AML Cohort (DDI Sub [...] ation-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole Part 3 AML Cohort (DDI Sub [...] imum Observed Plasma Concentration (Cmax) Of BGB-11417 When CoadministeredAdministered Alone and When Co-administe [...] [...]
2023-10-18
Study Status, Contacts/Locations v15
Study sites40→41
2023-09-26
Study Status, Contacts/Locations v14
Study sites39→40
2023-09-15
Study Status, Contacts/Locations v13
Study sites37→39
2023-08-24
Study Status, Contacts/Locations v12
Study sites36→37
2023-08-10
Study Status, Contacts/Locations v11
Study sites36 entries, revised
MiddlemoreMedical HospitalCollege of Wisconsin
2023-07-26
Study Status, Contacts/Locations v10
Study sites35→36
2023-07-21
Study Status, Contacts/Locations v9
Study sites58→35
2023-06-30
2 amendments v7-v8
2 re-verifications since 2023-06-05, no change to tracked fields
2023-05-26
Study Status, Contacts/Locations v6
Study sites24→58
2023-02-03
Study Status, Study Description v5
Re-verified, no change to tracked fields
2022-08-18
Study Identification, Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2023-02→2023-12
Completion date2024-06→2025-08
Enrollment target110→260
Study sites17→24
InterventionsAzacitidine (Drug), BGB-11417 (Drug), Posaconazole (Drug)→Azacitidine (Drug), BGB-11417 (Drug), BGB-11417 (Drug), BGB-11417 (Drug), Posaconazole (Drug)
Eligibility criteria-13 characters
[...] n criteria: AML, nonacute promyelocytic leukemia MDS MDS/MPN For treatment naïve AML, must be unfit for intensive chemotherapy Eastern Cooperative Oncology Group performance status of 0 [...] Adequate organ function defined as: Creatinine clearance ≥ 4550 milliliters/minute (mL/min) (or between 30 and 4549 mL/min in unfit AML cohort) Adequate liver function Life ex [...] or therapy with a B-cell lymphoma-2 inhibitor or azacitidine. except for participants who meet HMA-failure criteria Known central nervous system involvement by leukemia. Note: [...]
Secondary endpoints25 to 32 entries
Parts 1 And 2: t1/2 Of Azacitidine When Coadministered With BGB-11417 Part 3: CRComplete Response Part 3 AML Cohort: Event-free Survival (EFS) Part 3 AML Cohort: Overall Survival (OS) Part 3 AML Cohort: Number of Participants with Transfusion Independence Part 3 MDS Cohort: ProportionNumber Of Participants With Hematological Improvement-erythroid (HI-E) Part 3 MDS Cohort: Number of participants with Transfusion Independence Part 3 MDS cohort: Partial Hematologic Recovery CRh Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recov [...]
Primary endpoints6 to 9 entries
Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When CoadministeredCo-administered With Posaconazole Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable (AUC0-t) Of BGB-11417 When Co-administered With Posaconazole Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs Part 3 AML and MDS C [...]
2022-06-08
Study Status, Contacts/Locations v3
Study sites16→17
2022-01-24
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v2
Primary completion date2022-02→2023-02
Completion date2024-02→2024-06
Eligibility criteria+42 characters
[...] Organization criteria: AML, nonacute promyelocytic leukemia Treatment-naive (TN) MDS TN MDS/MPN For treatment naïve AML, must be unfit for intensive chemotherapy Eastern Cooperative Oncology Group performance status of 0 [...]
Study sitesdetails revised at 3 of 16 sites
2021-08-31
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-02→confirmed 2021-05-24
Study sites12→16
2021-02-23
Original filing
BeOne Medicines
59 trials monitored
See 7 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Acute Myeloid Leukemia (AML)
1,196 trials monitored
See 63 trials at risk
Myelodysplastic Syndromes (MDS)
685 trials monitored
See 40 trials at risk
and 1 more disease
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) .
Trial Details
NCT Number NCT04771130
Lead Sponsor BeOne Medicines
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm
Enrollment 260 participants
Start Date 2021-05-24
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-14