Clincosm LogoSign in Get a demo

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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02632721
Collaborator
(none)
49
Enrollment
14
Locations
4
Arms
78.5
Anticipated Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
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 monotherapyPhase I Dose Escalation: Open-label, single-arm, dose escalationTo 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 randomizedTo investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 16, 2016
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase I: Dose Escalation

Combination treatment of decitabine with escalating doses of BI 836858

Drug: Decitabine

Drug: BI 836858
Experimental: Phase I: Extension

Cohort A treated with BI 836858 plus intensive decitabine treatment schedule. Followed by Cohort B treated with BI 836858 plus standard decitabine treatment schedule.

Drug: Decitabine

Drug: BI 836858
Experimental: Phase II: Arm 1

Combination treatment of decitabine with BI 836858

Drug: Decitabine

Drug: BI 836858
Other: Phase II: Arm 2

Monotherapy treatment with decitabine (standard of care treatment)

Drug: Decitabine

Outcome Measures

Primary Outcome Measures

  1. Phase I: Number of patients with dose limiting toxicity (DLT(s)) during first treatment cycle [12 months]

  2. Phase II:Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) [30 months]

  3. Phase I: MTD of BI 836858 in combination with decitabine [60 months]

Secondary Outcome Measures

  1. Phase II: Event free survival (EFS) [60 months]

  2. Phase II: Relapse free survival (RFS) [60 months]

  3. Phase II: Remission duration [60 months]

  4. Phase II: Time to remission [60 months]

  5. Phase I: Number of patients with objective response combining - Complete remission (CR) - CR with incomplete blood count recovery (CRi) [60 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
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

  1. 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:

  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).

  1. Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Cancer Center Jacksonville Florida United States 32224
2 Northwestern University Chicago Illinois United States 60611
3 Northwell Health Lake Success New York United States 11042
4 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
5 Universitätsklinikum Augsburg Augsburg Germany 86156
6 Vivantes Netzwerk für Gesundheit GmbH Berlin Germany 10967
7 Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
8 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
9 Universitätsklinikum Jena Jena Germany 07740
10 Universitätsklinikum Münster Münster Germany 48149
11 A.O. Spedali Civili di Brescia Brescia Italy 25123
12 Hospital Vall d'Hebron Barcelona Spain 08035
13 Hospital Clínic de Barcelona Barcelona Spain 08036
14 Hospital Politècnic La Fe Valencia Spain 46026

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02632721
Other Study ID Numbers:
  • 1315.2
  • 2015-002892-30
  • 1315-0002
First Posted:
Dec 17, 2015
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Decitabine

Study Results

No Results Posted as of Aug 10, 2022