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Monoclonal Antibodies

BI 836858 for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until the earliest of progression, death or end of trial, up to 971 days.

Awards & highlights

Study Summary

This trial is testing a new drug, BI 836858, to see if it is safe and effective when used with the drug decitabine to treat acute myeloid leukemia. The trial has three phases. In the first phase, different doses of BI 836858 are tested to see what the maximum tolerated dose is. In the second phase, the safety and efficacy of BI 836858 in combination with decitabine is compared to decitabine alone. The third phase is designed to see if BI 836858 is effective in treating people with acute myeloid leukemia.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until the earliest of progression, death or end of trial, up to 971 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until the earliest of progression, death or end of trial, up to 971 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until the earliest of progression, death or end of trial, up to 971 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose (MTD) of BI 836858 in Combination With Decitabine

Phase I: Number of Patients With Dose Limiting Toxicity (DLT(s)) During First Treatment Cycle

Secondary outcome measures

Phase 1: Number of Patients With Objective Response (CR + CRi)

Side effects data

From 2023 Phase 1 & 2 trial • 49 Patients • NCT02632721

100%

Nausea

100%

Vomiting

100%

Infusion related reaction

67%

Febrile neutropenia

67%

Device related infection

67%

Abdominal pain upper

67%

Constipation

67%

Chills

67%

Fatigue

67%

Decreased appetite

67%

Platelet count decreased

67%

White blood cell count decreased

67%

Dyspnoea

67%

Hypertension

33%

Urinary incontinence

33%

Abdominal pain lower

33%

Stomatitis

33%

Abdominal pain

33%

Oedema peripheral

33%

Hypersensitivity

33%

Diarrhoea

33%

Non-cardiac chest pain

33%

Infection

33%

Pyrexia

33%

Sepsis

33%

Malignant neoplasm progression

33%

Anaemia

33%

Neutropenia

33%

Anal incontinence

33%

Dysphagia

33%

Toothache

33%

Chest discomfort

33%

Localised oedema

33%

Mucosal inflammation

33%

Urinary tract infection enterococcal

33%

Enterococcal infection

33%

Herpes simplex viraemia

33%

Sinusitis

33%

Oral herpes

33%

Transplantation complication

33%

Urinary tract infection

33%

Procedural pain

33%

Blood creatinine increased

33%

Cachexia

33%

C-reactive protein increased

33%

Weight decreased

33%

Neutrophil count decreased

33%

Lymphocyte count decreased

33%

Weight increased

33%

White blood cell count increased

33%

Hypokalaemia

33%

Hypervolaemia

33%

Back pain

33%

Bone pain

33%

Tremor

33%

Dizziness

33%

Atelectasis

33%

Muscular weakness

33%

Anogenital warts

33%

Adjustment disorder with depressed mood

33%

Restlessness

33%

Productive cough

33%

Nervousness

33%

Renal failure

33%

Vulvovaginal pain

33%

Upper-airway cough syndrome

33%

Hypoxia

33%

Thrombosis

33%

Nasal congestion

33%

Hypotension

33%

Petechiae

33%

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Phase I Dose Escalation: BI 836858 40 mg + Decitabine (Intensive)

Phase I Dose Escalation: BI 836858 80 mg + Decitabine (Intensive)

Phase I Dose Escalation: BI 836858 20 mg + Decitabine (Intensive)

Phase I Extension A: BI 836858 80 mg + Decitabine (Intensive)

Phase I Extension B: BI 836858 80 mg + Decitabine (Standard)

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase I dose escalation: BI 836858 80 mg + decitabine (intensive)Experimental Treatment2 Interventions

Dose escalation.

Group II: Phase I dose escalation: BI 836858 40 mg + decitabine (intensive)Experimental Treatment2 Interventions

Dose escalation.

Group III: Phase I dose escalation: BI 836858 20 mg + decitabine (intensive)Experimental Treatment2 Interventions

Dose escalation.

Group IV: Phase I Extension B: BI 836858 80 mg + decitabine (standard)Experimental Treatment2 Interventions

Extension phase.

Group V: Phase I Extension A: BI 836858 80 mg + decitabine (intensive)Experimental Treatment2 Interventions

Extension phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 836858

2016

Completed Phase 2

~100

Decitabine

2004

Completed Phase 3

~1680

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,823 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial available in many locations within the city?

"4 sites are enrolling patients for this trial, which include Northwestern University in Chicago, Northwell Health in Lake Success, The Ohio State University Wexner Medical Center in Columbus. There are 4 other locations not mentioned."

Answered by AI

What therapeutic benefits has BI 836858 been shown to have?

"BI 836858 is most typically used to treat patients at risk for ipss intermediate-2, but it can also be helpful for those with ipss high risk, refractory anemias, and anemia."

Answered by AI

What can you tell me about other research projects that have used BI 836858?

"At present, there are 106 clinical trials underway for BI 836858. Of these studies, 16 are in Phase 3 and recruiting patients. The majority of research is based out of Philadelphia, but there are 1529 centres running trials globally."

Answered by AI

Are we still receiving applications for this experiment?

"Unfortunately, this study is not seeking participants at the moment. The trial was initially posted on June 16th, 2016 and was last edited on November 14th, 2022. Although there are no plans to enroll patients presently, there are 1,626 other trials that are recruiting patients as we speak."

Answered by AI

How many people are volunteering for this clinical research?

"Currently, this particular trial is not enrolling patients. Although, it is important to note that the study was updated as recently as November 14th of this year. There are also other ongoing trials involving leukemia, myeloid and BI 836858 with 1520 and 106 active patient respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02632721.