Acute Myeloid LeukemiaPhase 2/3NCT00413439
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
A Phase 2/3 study testing Isavuconazole in people with Acute Myeloid Leukemia, run by Basilea Pharmaceutica at 4 sites in Germany.
Trial summary
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Isavuconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesGermany
- Study dates
- May 2006to Jun 2007
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of acute myeloid leukemia
- patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed
- expected to be neutropenic for >9 and <28 days after enrollment
- women of childbearing potential must have a negative pregnancy test
Who cannot join
- patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study
- patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months
- patients with fever defined as central body temperature of > 38°C
- known hypersensitivity to azoles or any component of the study medication
- concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine
- hepatic or severe renal dysfunction
Show all 10Show fewer
- patients with a medical history of oliguria unresponsive to fluid challenge
- patients with a concomitant medical condition that may be an unacceptable additional risk to the patient should he/she participate in the study
- treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols
- suspected other or additional cause for neutropenia or immunosuppression
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Study site
Bremen
University Cologne
Cologne, 50937
Study site
Frankfurt
Study site
Mainz
About this study
Official title: Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.
Read the detailed description
Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections, including fungal infections. As the failure rate in the treatment of invasive fungal infections is high, prophylaxis is frequently recommended. This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal, as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Isavuconazole
- Keywords
- Isavuconazole, BAL8557, ASP9766, chemotherapy, prophylaxis, systemic fungal infection
- 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.
IsavuconazoleDrug
Also called ASP9766, BAL8557
Intravenous solution or oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Low dose isavuconazole intravenous solution | Experimental | Not described Receives: Drug: Isavuconazole |
| High dose isavuconazole intravenous solution or oral capsules | Experimental | Not described Receives: Drug: Isavuconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)
Measured: Up to Day 28
Secondary outcomes (2)
Efficacy assessed by the frequency of invasive fungal infections
Measured: Up to Day 28
Pharmacokinetics: drug plasma levels
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Cornely, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413439
- Sponsor's protocol ID
- WSA-CS-002
- Other IDs
- 2005-005294-30, 2005
- Status last verified
- May 2023
- First submitted
- 18 Dec 2006
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Cornely OA, Bohme A, Schmitt-Hoffmann A, Ullmann AJ. Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study. Antimicrob Agents Chemother. 2015 Apr;59(4):2078-85. doi: 10.1128/AAC.04569-14. Epub 2015 Jan 26.
PubMed 25624327
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00413439
- Acronym / sponsor ID
- WSA-CS-002
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Isavuconazole, BAL8557, ASP9766, chemotherapy, prophylaxis, systemic fungal infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Dec 2006 (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.
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.
Detailed description
Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections, including fungal infections. As the failure rate in the treatment of invasive fungal infections is high, prophylaxis is frequently recommended. This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal, as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose isavuconazole intravenous solution | Experimental | Drug: Isavuconazole |
| High dose isavuconazole intravenous solution or oral capsules | Experimental | Drug: Isavuconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of acute myeloid leukemia
- patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed
- expected to be neutropenic for >9 and <28 days after enrollment
- women of childbearing potential must have a negative pregnancy test
Key exclusion criteria (10 listed)
- patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study
- patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months
- patients with fever defined as central body temperature of > 38°C
- known hypersensitivity to azoles or any component of the study medication
- concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine
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 |
|---|---|---|
| IsavuconazoleAlso: ASP9766, BAL8557Intravenous solution or oral capsules | Drug | High dose isavuconazole intravenous solution or oral capsules, Low dose isavuconazole intravenous solution |
Primary outcome
Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)
Time frame: Up to Day 28
2 secondary outcomes
Efficacy assessed by the frequency of invasive fungal infections
Time frame: Up to Day 28
Pharmacokinetics: drug plasma levels
Time frame: Up to Day 28
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 10 May 2023.
- Derived from this study: PubMed 25624327Cornely OA, Bohme A, Schmitt-Hoffmann A, Ullmann AJ. Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study. Antimicrob Agents Chemother. 2015 Apr;59(4):2078-85. doi: 10.1128/AAC.04569-14. Epub 2015 Jan 26.
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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.
Oliver Cornely, MD principal investigator
University of Cologne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Isavuconazole in people with Acute Myeloid Leukemia, run by Basilea Pharmaceutica at 4 sites in Germany.
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 4 inclusion and 10 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs) (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413439, which also lists 1 linked publication.
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 10 May 2023.