A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2023-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Leukemia, Myeloid, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Phase I Dose Escalation: Open-label, single-arm, dose escalation

\- To determine the maximum tolerated dose (MTD) and the recommended dose for Phase I Extension (RExP1D)

Phase I Extension: Open-label, two consecutive groups (cohort A and B) - To collect additional data on safety, pharmacokinetics and efficacy and to decide if the RExP1D will become the Recommended Phase II Dose (RP2D)

Phase II: Open-label, two-arm randomized

\- To investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy

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Decitabine

Intervention Type DRUG

BI 836858

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

1. Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
2. Patients who are candidates for allogeneic stem cell transplantation.
3. Active chronic graft versus host disease requiring immunosuppressive treatment.
4. Phase I extension and Phase II only:

Prior treatment with a hypomethylating agent, such as prior treatment for Myelodysplastic Syndrome (MDS).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No