BI 836858 Dose Escalation in Refractory or Relapsed Acute Myeloid Leukemia
Conditions
Leukemia, Myeloid, Acute
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: BI 836858
Type: Drug
Overall Status
Recruiting
Summary
Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. The trial will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose levels.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion criteria:

1. Diagnosis of relapsed or refractory AML with at least one prior treatment for acute myeloid leukemia.

2. Expression of CD33 on more than 30% of bone marrow blasts.

3. Eastern Cooperative Oncology Group Performance Status 0, 1 or 2

4. Age 18 years or older

5. Written informed consent which is consistent with International Conference on Harmonization ¿ Good Clinical Practice (ICH-GCP) guidelines and local legislation.

Exclusion criteria:

1. Patients with acute promyelocytic leukemia according to WHO definition.

2. Patients with > 5.000 leukocytes/µl in the peripheral blood

3. Anti-leukemia therapy within two weeks before first treatment with BI 836858, 4 weeks for biologics

4. Allogeneic stem cell transplantation within the last 3 months or with evidence of graft versus host disease

5. Patients who are candidates for allogeneic stem cell transplantation.

6. Second malignancy currently requiring active therapy.

7. Symptomatic central nervous system involvement

8. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN), or AST or ALT greater than 5 times the ULN for those with Gilbert syndrome.

9. Prothrombin time (PT) >1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)

10. Bilirubin greater than 1.5 mg/dl (>26 µmol/L) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert syndrome, or hemolysis.

11. Serum creatinine greater than 2.0 mg/dl

12. Known human immunodeficiency virus (HIV) infection or active hepatitis B virus or hepatitis C virus infection.

13. Concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia

14. Psychiatric illness or social situation that would limit compliance with trial requirements

15. Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug

16. Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of BI 836858

17. Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for 6 months after the last administration of BI 836858

18. Pregnant or nursing female patients

19. Treatment with another investigational agent under the following conditions:

1. Within two weeks (4 weeks for biologics) of first administration of BI 836858; or

2. Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator.

3. Concomitant treatment with another investigational agent while participating in this trial.

20. Prior treatment with a CD33 antibody

21. Patient unable or unwilling to comply with the protocol.
Locations
1315.1.1003 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
Status: Recruiting
1315.1.1004 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
Status: Recruiting
1315.1.1002 Boehringer Ingelheim Investigational Site
New York, New York, United States
Status: Completed
1315.1.1001 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
Status: Recruiting
Start Date
September 2012
Completion Date
April 2016
Sponsors
Boehringer Ingelheim
Source
Boehringer Ingelheim
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page