Leukemia, Myeloid, AcutePhase 2NCT00701766
BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia
A Phase 2 study testing BI 2536 in people with Leukemia, Myeloid, Acute, run by Boehringer Ingelheim at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- BI 2536
- How many people
- 71 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2006to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany7 sites
1216.20.49006 Boehringer Ingelheim Investigational Site
Bonn
1216.20.49002 Boehringer Ingelheim Investigational Site
Frankfurt
1216.20.49003 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1216.20.49004 Boehringer Ingelheim Investigational Site
Hannover-Heideviertel
1216.20.49007 Boehringer Ingelheim Investigational Site
Heidelberg
1216.20.49005 Boehringer Ingelheim Investigational Site
Münster
1216.20.49001 Boehringer Ingelheim Investigational Site
Ulm
Austria2 sites
1216.20.43001 Boehringer Ingelheim Investigational Site
Innsbruck
1216.20.43002 Boehringer Ingelheim Investigational Site
Vienna
About this study
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
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.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- BI 2536
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 2536Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose Best objective response
Measured: 3 weeks, throughout the study period
Secondary outcomes (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
Measured: throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startOct 2006
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701766
- Sponsor's protocol ID
- 1216.20
- Other IDs
- EudraCT No:2006-000613-38
- Status last verified
- Oct 2013
- First submitted
- 18 Jun 2008
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00701766
- Acronym / sponsor ID
- 1216.20
- Conditions
- Leukemia, Myeloid, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 2536 | Drug | – |
Primary outcome
Maximum tolerated dose Best objective response
Time frame: 3 weeks, throughout the study period
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 2536 in people with Leukemia, Myeloid, Acute, run by Boehringer Ingelheim at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose Best objective response (time frame: 3 weeks, throughout the study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.