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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. Identifier: NCT00701766
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : May 16, 2014
Information provided by:
Boehringer Ingelheim

Brief Summary:
The present trial will be performed to determine the MTD and to evaluate the efficacy of BI 2536 in the treatment of elderly patients with relapsed or refractory AML. Different schedules will be compared to identify the better dosing schedule for the further development programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously determined in patients with advanced solid cancers will be performed to determine the maximum tolerated dose for AML patients.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: BI 2536 Phase 2

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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

Primary Outcome Measures :
  1. Maximum tolerated dose Best objective response [ Time Frame: 3 weeks, throughout the study period ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00701766

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1216.20.43001 Boehringer Ingelheim Investigational Site
Innsbruck, Austria
1216.20.43002 Boehringer Ingelheim Investigational Site
Wien, Austria
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
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim 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
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type