BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00701766 |
Recruitment Status :
Completed
First Posted : June 19, 2008
Last Update Posted : May 16, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia, Myeloid, Acute | Drug: BI 2536 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Intervention Model: | Parallel Assignment |
Primary Purpose: | Treatment |
Official Title: | An Open, Randomised Clinical Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Efficacy, Safety and Pharmacokinetics of Repeated Three-week Courses of a Single Dose i.v. BI 2536 on Day 1 in Comparison to Single Doses i.v. BI 2536 on Days 1, 2 and 3 in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | October 2009 |

- Maximum tolerated dose Best objective response [ Time Frame: 3 weeks, throughout the study period ]
- Event free survival, Overall survival, Remission duration, BI 2536 plasma concentrations, Incidence and intensity of adverse events graded according to CTCAE, PD, Incidence of DLT [ Time Frame: throughout the study period ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients older than 60 years of age
- Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy
- Leukocyte count <= 25,000 /mcl (25 x 10e9/Liter)
- Patient not eligible for intensive treatment options
- Life expectancy >= 2 months
- Eastern co-operative oncology group performance score of 2 or less
- Signed written informed consent consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation
Exclusion Criteria:
- Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3)
- Hypersensitivity to the trial drug or the excipients
- Secondary malignancy requiring therapy
- Known central nervous system involvement
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement
- Bilirubin greater than 1.5 mg/dl (> 26 mcmol/l, SI unit equivalent)
- Serum creatinine greater than 2.0 mg/dl
- 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
- Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug
- Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant
- 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.)
- Patient unable to comply with the protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701766
Austria | |
1216.20.43001 Boehringer Ingelheim Investigational Site | |
Innsbruck, Austria | |
1216.20.43002 Boehringer Ingelheim Investigational Site | |
Wien, Austria | |
Germany | |
1216.20.49006 Boehringer Ingelheim Investigational Site | |
Bonn, Germany | |
1216.20.49002 Boehringer Ingelheim Investigational Site | |
Frankfurt, Germany | |
1216.20.49003 Boehringer Ingelheim Investigational Site | |
Freiburg, Germany | |
1216.20.49004 Boehringer Ingelheim Investigational Site | |
Hannover-Heideviertel, Germany | |
1216.20.49007 Boehringer Ingelheim Investigational Site | |
Heidelberg, Germany | |
1216.20.49005 Boehringer Ingelheim Investigational Site | |
Münster, Germany | |
1216.20.49001 Boehringer Ingelheim Investigational Site | |
Ulm, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00701766 |
Other Study ID Numbers: |
1216.20 EudraCT No:2006-000613-38 |
First Posted: | June 19, 2008 Key Record Dates |
Last Update Posted: | May 16, 2014 |
Last Verified: | October 2013 |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |