Back to resultsBI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
Primary Purpose
Leukemia, Myeloid, Acute
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
BI 811283 (d 1 and 15)
Cytarabine
BI 811283 (d1)
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute
Eligibility Criteria
Inclusion criteria:
- Male or female adult with previously untreated acute myeloid leukaemia (AML)
- Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
- Patient is considered ineligible for intensive treatment
- Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
- Life expectancy > 3 months
- Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
- Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
Exclusion criteria:
- Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
- Relapsed or treatment refractory AML.
- Hypersensitivity to one of the trial drugs or the excipients.
- Other malignancy requiring treatment.
- Known central nervous system involvement.
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN).
- INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
- Bilirubin greater than 1.5 mg/dl.
- Serum creatinine greater than 2.0 mg/dl.
- LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
- Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
- Psychiatric illness or social situation that would limit compliance with trial requirements.
- Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
- Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
- Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
- Pregnant or nursing female patients.
- Patient unable to comply with the protocol.
Sites / Locations
- 1247.3.49007 Boehringer Ingelheim Investigational Site
- 1247.3.49005 Boehringer Ingelheim Investigational Site
- 1247.3.49004 Boehringer Ingelheim Investigational Site
- 1247.3.49006 Boehringer Ingelheim Investigational Site
- 1247.3.49003 Boehringer Ingelheim Investigational Site
- 1247.3.49002 Boehringer Ingelheim Investigational Site
- 1247.3.49001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Schedule A
Schedule B
Arm Description
BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10
BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10
Outcomes
Primary Outcome Measures
The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.
The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only.
It was determined using a standard "3 + 3 design with de-escalation".
Secondary Outcome Measures
Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])
Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria:
The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with < 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets > 100,000/μL.
Complete remission with incomplete blood count recovery ("incomplete" CR, CRi).All of the above criteria for CR had to be met, except that neutrophils < 1,000/μL or platelets < 100,000/μL in the blood.
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
The severity and timing of AEs indicates how well the treatment regimen was tolerated.
Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme.
Incidence of Dose Limiting Toxicity (DLT)
Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)
Partial Remission
Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology.
Event Free Survival (EFS)
EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.
Relapse Free Survival
Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first.
Number of patients having relapse free survival are presented.
Remission Duration
Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.
Overall Survival (OS)
OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.
Cmax (Maximum Measured Concentration of BI 811283 in Plasma)
Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1
AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1
AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1
Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)
Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1
AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State
AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1
AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State
AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1
Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)
tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1
Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)
tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1
Cmax (Maximum Measured Concentration of Cytarabine in Plasma)
Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)
Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Pharmacodynamic Monitoring
Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes).
An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material.
Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone
The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol" -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010).
Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00632749
Brief Title
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
Official Title
An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Efficacy and Pharmacokinetics of BI 811283 in Combination With Cytarabine in Patients With Previously Untreated Acute Myeloid Leukaemia Ineligible for Intensive Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schedule A
Arm Type
Experimental
Arm Description
BI 811283 on days 1 and 15 in combination with Cytarabine 20 mg twice daily on Days 1-10
Arm Title
Schedule B
Arm Type
Experimental
Arm Description
BI 811283 on Day 1 in combination with Cytarabine 20 mg twice daily on Days 1-10
Intervention Type
Drug
Intervention Name(s)
BI 811283 (d 1 and 15)
Intervention Description
BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
BI 811283 (d1)
Intervention Description
BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
Primary Outcome Measure Information:
Title
The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.
Description
The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only.
It was determined using a standard "3 + 3 design with de-escalation".
Time Frame
up to 28 days of treatment
Secondary Outcome Measure Information:
Title
Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])
Description
Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria:
The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with < 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets > 100,000/μL.
Complete remission with incomplete blood count recovery ("incomplete" CR, CRi).All of the above criteria for CR had to be met, except that neutrophils < 1,000/μL or platelets < 100,000/μL in the blood.
Time Frame
Data collected up to cut-off date 20Oct2011, Up to 1239 days
Title
Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)
Description
The severity and timing of AEs indicates how well the treatment regimen was tolerated.
Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme.
Time Frame
Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days
Title
Incidence of Dose Limiting Toxicity (DLT)
Description
Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)
Time Frame
up to 28 days of treatment
Title
Partial Remission
Description
Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.
Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology.
Time Frame
Data collected up to cut-off date 20 Oct 2011, Up to 1239 days
Title
Event Free Survival (EFS)
Description
EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.
Time Frame
Data collected up to cut-off date 20 Oct 2011, Up to 1239 days
Title
Relapse Free Survival
Description
Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first.
Number of patients having relapse free survival are presented.
Time Frame
Data collected up to cut-off date 20 Oct 2011, Up to 1239 days
Title
Remission Duration
Description
Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.
Time Frame
Data collected up to cut-off date 20 Oct 2011, Up to 1239 days
Title
Overall Survival (OS)
Description
OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.
Time Frame
Data collected up to cut-off date 20 Oct 2011, Up to 1239 days
Title
Cmax (Maximum Measured Concentration of BI 811283 in Plasma)
Description
Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Description
AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Description
AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)
Description
Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State
Description
AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State
Description
AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)
Description
tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)
Description
tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1
Time Frame
-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283
Title
Cmax (Maximum Measured Concentration of Cytarabine in Plasma)
Description
Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Time Frame
-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine
Title
Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)
Description
Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Time Frame
-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine
Title
AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Description
AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Time Frame
-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine
Title
AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Description
AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283
Time Frame
-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine
Title
Pharmacodynamic Monitoring
Description
Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes).
An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material.
Time Frame
On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only
Title
Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone
Description
The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol" -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010).
Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated.
Time Frame
-0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male or female adult with previously untreated acute myeloid leukaemia (AML)
Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
Patient is considered ineligible for intensive treatment
Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
Life expectancy > 3 months
Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
Exclusion criteria:
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
Relapsed or treatment refractory AML.
Hypersensitivity to one of the trial drugs or the excipients.
Other malignancy requiring treatment.
Known central nervous system involvement.
Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN).
INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
Bilirubin greater than 1.5 mg/dl.
Serum creatinine greater than 2.0 mg/dl.
LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
Psychiatric illness or social situation that would limit compliance with trial requirements.
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
Pregnant or nursing female patients.
Patient unable to comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1247.3.49007 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1247.3.49005 Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
1247.3.49004 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1247.3.49006 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1247.3.49003 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
1247.3.49002 Boehringer Ingelheim Investigational Site
City
Münster
Country
Germany
Facility Name
1247.3.49001 Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30450591
Citation
Dohner H, Muller-Tidow C, Lubbert M, Fiedler W, Kramer A, Westermann J, Bug G, Schlenk RF, Krug U, Goeldner RG, Hilbert J, Taube T, Ottmann OG. A phase I trial investigating the Aurora B kinase inhibitor BI 811283 in combination with cytarabine in patients with acute myeloid leukaemia. Br J Haematol. 2019 May;185(3):583-587. doi: 10.1111/bjh.15563. Epub 2018 Nov 19. No abstract available.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
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