A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | June 16, 2016 |
| End Date: | November 30, 2020 |
| Contact: | Boehringer Ingelheim Call Center |
| Email: | clintriage.rdg@boehringer-ingelheim.com |
| Phone: | 1-800-243-0127 |
An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
Phase I Dose Escalation: Primary objective is to determine the 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.
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.
Inclusion criteria:
- Phase I Dose Escalation:
1. Male or female patients >/= 18 years of age with relapsed or refractory AML
2. 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
- Patients must be eligible for treatment with decitabine
- Eastern co-operative oncology group (ECOG) performance score 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 MDS.
- Prior treatment with Cluster of differentiation 33 (CD33) antibody Further exclusion
criteria apply.
We found this trial at
6
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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