LeukemiaPhase 2NCT01018069
AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
A Phase 2 study testing AEG35156 in people with Leukemia, run by Aegera Therapeutics at 18 sites in 3 countries.
Trial summary
To determine if AEG35156 can enhance the combined complete remission (CR) and CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- AEG35156
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Nov 2009to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
- Patients must have adequate organ and immune function as indicated by the following laboratory values:
- Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
- The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
Who cannot join
- Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
- Patients with a prior history of peripheral neuropathy of grade 2 or higher.
- Clinical evidence of active CNS leukemic involvement.
- Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
- Current evidence of invasive fungal infection (blood or tissue culture).
- Current evidence of an active second malignancy except for non-melanoma skin cancer.
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- Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
- Neurological or psychiatric disorders that would interfere with consent or study follow-up.
- Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
- History of alcohol or other substance abuse within the last year.
- Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
- Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Germany8 sites
Klinikum Chemnitz gGmbH
Chemnitz, 09113
St. Johannes Hospital
Duisburg, 47166
Universitatsklinimum Essen
Essen, 45147
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
2. Medizinische Klinik und Poliklinik im Stadtischen Krankenhaus Kile GmgH
Kiel, 24116
III. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universitat
Mainz, 55131
Medizinische Klinik a Hamatologie und Onkologie
Münster, 48129
Robert Boasch Krankenhaus Stuttgart
Stuttgart, 70376
United States6 sites
Northwestern University Med School, div. Oncology & Hematology
Chicago, Illinois, 60611
Rocky Mountain Blood & Marrow Transplant Program
Denver, Colorado, 80218
MD Anderson Cancer Center University of Texas
Houston, Texas, 77303
UCLA School of Medicine
Los Angeles, California, 90095
Cancer Research Institute of Scott & White Hospital
Temple, Texas, 76502
New York Medical College
Valhalla, New York, 10595
Canada4 sites
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Hopital Sacre Coeur
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario
About this study
Official title: An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
To determine if AEG35156 can enhance the combined complete remission (CR) and CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
- Conditions
- Leukemia
- Being tested
- AEG35156
- Keywords
- Acute, myeloid, leukemia, antisense, chemotherapy, idarubicin, cytarabine, Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen.
- Medical subject headings
- Leukemia, Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEG35156Drug
2 hr infusion of 650 mg of AEG35156 on days 1, 2, 3 and 8. Idarubicin 12 mg/m2 over 30 minutes daily on each of days 4, 5 and 6. The dose of cytarabine will be 1.5 g/m2 daily by continuous infusion x 4 days (days 4-7) in patients under age 65 and x 3 days (days 4-6) in patients age 65 and above.
| Study group | Role | What they receive |
|---|---|---|
| AEG35156 | Active comparator | Patient receive AEG35156 prior to chemotherapy Receives: Drug: AEG35156 |
| Control | Sham comparator | Patients receive chemotherapy only Receives: Drug: AEG35156 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if AEG35156 can enhance the CR and CR with incomplete platelet recovery (CRp) rate and duration of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
Measured: 1 year
Secondary outcomes (1)
To determine if AEG35156 can enhance overall survival, is safe and measured (Pharmacokinetic) following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Failed to reach endpoints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aegera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aaron Schimmer, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018069
- Sponsor's protocol ID
- AEG35156-206
- Other IDs
- 2009-013669-25, 2009
- Status last verified
- Jul 2011
- First submitted
- 19 Nov 2009
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
- ClinicalTrials.gov ID
- NCT01018069
- Acronym / sponsor ID
- AEG35156-206
- Conditions
- Leukemia
- Keywords
- Acute, myeloid, leukemia, antisense, chemotherapy, idarubicin, cytarabine, Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to reach endpoints
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aegera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Nov 2009 (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.
To determine if AEG35156 can enhance the combined complete remission (CR) and CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AEG35156 | Active comparator | Drug: AEG35156Patient receive AEG35156 prior to chemotherapy |
| Control | Sham comparator | Drug: AEG35156Patients receive chemotherapy only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
- Patients must have adequate organ and immune function as indicated by the following laboratory values:
- Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
Key exclusion criteria (12 listed)
- Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
- Patients with a prior history of peripheral neuropathy of grade 2 or higher.
- Clinical evidence of active CNS leukemic involvement.
- Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
- Current evidence of invasive fungal infection (blood or tissue culture).
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 |
|---|---|---|
| AEG351562 hr infusion of 650 mg of AEG35156 on days 1, 2, 3 and 8. Idarubicin 12 mg/m2 over 30 minutes daily on each of days 4, 5 and 6. The dose of cytarabine will be 1.5 g/m2 daily by continuous infusion x 4 days (days 4-7) in patients under age 65 and x 3 days (days 4-6) in patients age 65 and above. | Drug | AEG35156, Control |
Primary outcome
To determine if AEG35156 can enhance the CR and CR with incomplete platelet recovery (CRp) rate and duration of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
Time frame: 1 year
1 secondary outcome
To determine if AEG35156 can enhance overall survival, is safe and measured (Pharmacokinetic) following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Failed to reach endpoints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
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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.
Aaron Schimmer, MD principal investigator
Princess Margaret Hospital, Canada
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AEG35156 in people with Leukemia, run by Aegera Therapeutics at 18 sites in 3 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, United States, Canada. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Failed to reach endpoints). Results are not available in the source record.
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?
To determine if AEG35156 can enhance the CR and CR with incomplete platelet recovery (CRp) rate and duration of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. (time frame: 1 year). 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 13 Jul 2011.