18 and older, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Dose Limiting Toxicity (DLT) (Phase I)Primary· From the first administration of BI 836858 to start of the third administration of BI 836858, excluding the day of the third administration of BI 836858, up to 28 days
Dose Limiting Toxicity (DLT):
* Grade (G) ≥ 3 (CTCAE 4.0), non disease-related, non-hematologic adverse events (AE), except:
* Laboratory abnormality, not significant by investigator or resolves spontaneously or can be recovered with appropriate treatment (T) within 5 d
* Neutrophils (NP) \<500 /microliters (μL) at T start, febrile neutropenia with NP \<500 /μL or infection with NP \<500 /μL will not constitute a DLT if they can be recovered with appropriate T within 14 d
* Inability to deliver study drug full dose according to the assigned dose level within cycle 1 due to drug-related A
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
1
BI 836858 160 mg (Phase I)
0
BI 836858 320 mg (Phase I)
2
Number of Patients With Red Blood Cell (RBC) Transfusion Independency (Phase I)Secondary· From first administration of BI 836858 until discontinuation of the treatment. Up to 168 days (6 cycles, each of 28 days)
Number of patients with red blood cell (RBC) Transfusion Independency is presented.
Red blood cell (RBC) transfusion independence and platelet transfusion independence will be evaluated in patients who are transfusion dependent at baseline. Percentages will be calculated using all treated patients as the denominator.
A patient is considered transfusion independent at baseline if the patient has had no transfusions during the 56 days prior to and including the first day of treatment. Otherwise, the patient is considered to be transfusion dependent.
A patient is considered transfusion indepen
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
0
BI 836858 160 mg (Phase I)
0
BI 836858 320 mg (Phase I)
0
Number of Patients With Hematologic Improvement Neutrophils (HI-N) (Phase I)Secondary· From first administration of BI 836858 until HI-N, up to 168 days (6 cycles, each of 28 days)
Number of patients with hematologic improvement neutrophils (HI-N) is presented.
The HI will be evaluated in patients with abnormal pretreatment values defined as follows:
Neutrophil response (HI-N) - Patients with a pretreatment neutrophil count \<1 x 10\^9/liters (L) demonstrate a neutrophil response if they have an at least 100 percent increase and an absolute increase \>0.5 x 10\^9/L.
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
0
BI 836858 160 mg (Phase I)
0
BI 836858 320 mg (Phase I)
0
Number of Patients With Hematologic Improvement Platelets (HI-P) (Phase I)Secondary· From first administration of BI 836858 until HI-P, up to 168 days (6 cycles, each of 28 days)
Number of patients with hematologic improvement platelets (HI-P) is presented.
The HI will be evaluated in patients with abnormal pretreatment values defined as follows:
Platelet response (HI-P) - Patients with a pretreatment platelet count \<100 x 109/Liters (L) demonstrate a platelet response if there is an absolute platelet increase of ≥30 x 109/L for patients starting with \>20 x 109/L platelets. For those with an increase from 10 x 109/L to \>20 x 109/L must have an increase of at least 100 percent.
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
0
BI 836858 160 mg (Phase I)
0
BI 836858 320 mg (Phase I)
0
Number of Patients With Hematologic Improvement Erythroid (HI-E) (Phase I)Secondary· From first administration of BI 836858 until HI-E, up to 168 days (6 cycles, each of 28 days)
Number of patients with hematologic improvement erythroid (HI-E) is presented.
The HI will be evaluated in patients with abnormal pretreatment values defined as follows:
Erythroid response (HI-E): Patients with a pretreatment hemoglobin \<11 grams per deciliters (g/dL) demonstrate erythroid response if their hemoglobin increases by ≥1.5 g/dL for at least eight weeks, and there is a reduction in the units of red cell transfusions by an absolute number of at least four red cell transfusions per eight weeks compared with the pretreatment transfusion number in the previous eight weeks. Only red
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
0
BI 836858 160 mg (Phase I)
0
BI 836858 320 mg (Phase I)
0
Number of Patients With Mean Hemoglobin Increase ≥ 1.5 g/dL (Phase I)Secondary· Up to 48 weeks
Number of patients with mean hemoglobin increase ≥ 1.5 grams per deciliters (g/dL) is presented.
Mean hemoglobin increase ≥ 1.5 g/dL - Proportion of subjects achieving hemoglobin (Hgb) increase from baseline ≥ 1.5 g/dL over any consecutive 56-day period in absence of Red blood cell (RBC) transfusions.
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
0
BI 836858 160 mg (Phase I)
1
BI 836858 320 mg (Phase I)
0
Number of Patients With Overall Objective Response (OR) [Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI)] (Phase I)Secondary· From first administration of BI 836858 until overall objective response, up to 168 days (6 cycles, each of 28 days)
Number of patients with overall Objective Response (OR) \[Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI)\] is presented.
Overall Objective Response is defined as Complete Response (CR), Partial Response (PR), HI-N, HI-P, or HI-E. A patient's " Overall Objective Response " = "Yes" if one of these responses was reported at least once throughout the trial.
CR defined as: -Bone marrow: \<5 % blasts with normal maturation of all cell lines (Dysplastic changes should consider the normal range of dysplastic changes), persistent dysplasia will be noted; -Peripheral b
Group
Value
95% CI
BI 836858 20 mg (Phase I)
0
BI 836858 40 mg (Phase I)
0
BI 836858 80 mg (Phase I)
0
BI 836858 160 mg (Phase I)
0
BI 836858 320 mg (Phase I)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first administration of BI 836858 until end of residual effect period (REP), up to 198 days. For all-cause mortality from first administration of BI 836858 until end of follow-up, up to 198 days + 6 months follow-up..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BI 836858 20mg
Serious: 2/3 (67%)
Deaths: 1/3
BI 836858 40mg
Serious: 2/3 (67%)
Deaths: 0/3
BI 836858 80mg
Serious: 3/6 (50%)
Deaths: 1/6
BI 836858 160mg
Serious: 0/4 (0%)
Deaths: 0/4
BI 836858 320mg
Serious: 6/11 (55%)
Deaths: 3/11
Serious adverse events (23 terms)
Reaction
System
BI 836858 20mg
BI 836858 40mg
BI 836858 80mg
BI 836858 160mg
BI 836858 320mg
Infusion related reaction
Injury, poisoning and procedural complications
—
—
—
—
—
Acute coronary syndrome
Cardiac disorders
—
—
—
—
—
Ventricular tachycardia
Cardiac disorders
—
—
—
—
—
Non-cardiac chest pain
General disorders
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
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—
Enterocolitis infectious
Infections and infestations
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—
—
—
—
Infection
Infections and infestations
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—
—
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Sepsis
Infections and infestations
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Staphylococcal infection
Infections and infestations
—
—
—
—
—
Wound infection
Infections and infestations
—
—
—
—
—
Fall
Injury, poisoning and procedural complications
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—
—
—
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Spinal compression fracture
Injury, poisoning and procedural complications
—
—
—
—
—
Subdural haematoma
Injury, poisoning and procedural complications
—
—
—
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
—
—
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
—
—
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
—
Delirium
Psychiatric disorders
—
—
—
—
—
Renal cyst
Renal and urinary disorders
—
—
—
—
—
Lung infiltration
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
Other adverse events (119 terms — click to expand)
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino
· Phase 3
· recruiting
NCT05024513 — Biliary Drainage Plus HAIC in Locally Advanced pCCA
· Phase 2
· completed
NCT04743804 — Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
· Phase 3
· terminated
NCT04557735 — Study of Ravulizumab in Pediatric Participants With HSCT-TMA
· Phase 3
· completed
NCT04456413 — Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection
· Phase 2
· terminated
Other recruiting trials for Myelodysplastic Syndromes
Currently open trials in the same condition.
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer
· Phase 2
· recruiting
NCT06303193 — Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or
· Phase 1, PHASE2
· recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove
· EARLY_PHASE1
· recruiting
NCT06487247 — HEME Home Transfusion Program
· NA
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 21 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02240706.