Phase 2
Completed N=49
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Leukemia, Myeloid, Acute
Source: ClinicalTrials.gov NCT02632721 ↗
Enrolled (actual)
49
Serious AEs
93.9%
Results posted
Mar 2024
Primary outcomePrimary: Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle — 0; 0; 0; 1 Participants
Summary
Phase I Dose Escalation:
Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension.
Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine
Phase I Extension:
Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.
Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle |
0; 0; 0; 1; 1 | — |
| PRIMARY Phase I: Maximum Tolerated Dose (MTD) of BI 836858 in Combination With Decitabine |
NA | — |
| SECONDARY Phase 1: Number of Patients With Objective Response (CR + CRi) |
2; 0; 6; 7; 4; 1 | — |
Eligibility Criteria
Inclusion criteria
1)
Phase I Dose Escalation:
- Male or female patients >/= 18 years of age with relapsed or refractory AML
- Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy
Phase I Extension and Phase II:
-- Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy
- Histologically or cytologically confirmed AML according to the WHO classification 3) Patients must be eligible for treatment with decitabine 4) Eastern co-operative oncology group (ECOG) performance score </=2 at screening Further inclusion criteria apply.
Exclusion criteria
- Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
- Patients who are candidates for allogeneic stem cell transplantation.
- Active chronic graft versus host disease requiring immunosuppressive treatment.
- Phase I extension and Phase II only:
Prior treatment with a hypomethylating agent, such as prior treatment for Myelodysplastic Syndrome (MDS).
- Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT02632721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.