Acute Myeloid LeukemiaPhase 1NCT01332786
Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia
A Phase 1 study testing Tigecycline in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia. 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?
- Tigecycline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2011to Jan 2015
- Phase
- Phase 1
- 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
- Age >18 years
- Diagnosis of relapsed or refractory AML for which all potentially curative or standard salvage therapy options have been exhausted; OR AML without prior treatment who are not eligible for induction chemotherapy as defined as age > or equal to 80 or age > 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as LVEF less than 40% and/or DlCO less than 60% expected
- ECOG 0-2 performance status
- Biochemical values within the following range
- Serum creatinine <2x upper limit of normal
- Total bilirubin <1.5x upper limit of normal
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- AST and ALT <2x upper limit of normal
- Recovery from non-hematologic toxicity from prior chemotherapy
- Able and willing to provide informed consent
Who cannot join
- Allergy to tetracycline or minocycline
- Uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection
- Active systemic bacterial, fungal, or viral infection
- Concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis
- Pregnant or breast feeding
- Known active CNS involvement with AML
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- Neurologic symptoms related to uncontrolled illnesses or unexplained causes
- Psychiatric illness that would limit compliance with study
- Receiving systemic chemotherapy other than hydroxyurea to control circulating blast counts. Concomitant hydroxyurea is permitted, but only in the first cycle of therapy
- Prior therapy with tigecycline as an anti-cancer therapy or any use of the drug in the last month
- Use of other investigational anti-leukemic therapy within 14 days of registration
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Phase 1 Study Evaluating the Tolerance and Biologic Activity of Intravenous Infusions of Tigecycline in Patients With Relapsed or Refractory AML
The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.
Read the detailed description
Relapsed and refractory hematologic malignancies have poor responses to standard therapy and are associated with a poor prognosis. For example, relapsed acute myeloid leukemia (AML) is a highly aggressive and resistant disease, particularly when associated with first complete response (CR) duration of less than 12 months. Thus, there is an urgent need for new agents in relapsed and refractory hematologic malignancies such as acute leukemia. In elderly patients, where the tolerance of aggressive induction therapy is often poor and curative options such as bone marrow transplantation HSCT are not available, the need for effective non-aggressive drug regimens for AML is even greater.
Tigecycline is a glycylcycline derivative of tetracycline. Tigecycline is currently indicated for the treatment of complicated skin and skin structure infections, and complicated intra-abdominal infections. This clinical trial is a Phase I dose escalation study of tigecycline in patients with relapsed or refractory AML or those with newly diagnosed disease not eligible for induction chemotherapy.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Tigecycline
- Keywords
- AML
- 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.
TigecyclineDrug
Also called Tygacil
Dosage Form: one-hour intravenous infusion Dosage levels, frequency, duration: (3-week cycles)
- Level 1: 50 mg daily x 10 doses; 1 week rest
- Level 2: 100 mg daily x 10 doses; 1 week rest
- Level 3: 150 mg daily x 10 doses; 1 week rest
- Level 4: 200 mg daily x 10 doses 1 week rest
- Level 5: 250 mg daily x 10 doses; 1 week rest
- Level 6: 300 mg daily x 10 doses; 1 week rest
- Level 7: 350 mg daily x 10 doses; 1 week rest
| Study group | Role | What they receive |
|---|---|---|
| Tigecycline | Experimental | Not described Receives: Drug: Tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity evaluated according to CTCAE version 4.03
Measured: Reviewed at each visit and assessed at the end of each 3-week cycle
Secondary outcomes (1)
Response rate assessment of tigecycline through laboratory assessments
Bone marrow assessment, absolute neutrophil count, platelet counts
Measured: Assessed at the end of each 3-week cycle for the study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, Memorial Sloan Kettering Cancer Center, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Aaron Schimmer, MD, Study director, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332786
- Sponsor's protocol ID
- OZM-029
- Status last verified
- Apr 2015
- First submitted
- 31 Mar 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Evaluating the Tolerance and Biologic Activity of Intravenous Infusions of Tigecycline in Patients With Relapsed or Refractory AML
- ClinicalTrials.gov ID
- NCT01332786
- Acronym / sponsor ID
- OZM-029
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Kansas, Memorial Sloan Kettering Cancer Center, University of California, Los Angeles
- Study start
- Mar 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Apr 2011 (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 purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.
Detailed description
Relapsed and refractory hematologic malignancies have poor responses to standard therapy and are associated with a poor prognosis. For example, relapsed acute myeloid leukemia (AML) is a highly aggressive and resistant disease, particularly when associated with first complete response (CR) duration of less than 12 months. Thus, there is an urgent need for new agents in relapsed and refractory hematologic malignancies such as acute leukemia. In elderly patients, where the tolerance of aggressive induction therapy is often poor and curative options such as bone marrow transplantation HSCT are not available, the need for effective non-aggressive drug regimens for AML is even greater.
Tigecycline is a glycylcycline derivative of tetracycline. Tigecycline is currently indicated for the treatment of complicated skin and skin structure infections, and complicated intra-abdominal infections. This clinical trial is a Phase I dose escalation study of tigecycline in patients with relapsed or refractory AML or those with newly diagnosed disease not eligible for induction chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tigecycline | Experimental | Drug: Tigecycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years
- Diagnosis of relapsed or refractory AML for which all potentially curative or standard salvage therapy options have been exhausted; OR AML without prior treatment who are not eligible for induction chemotherapy as defined as age > or equal to 80 or age > 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as LVEF less than 40% and/or DlCO less than 60% expected
- ECOG 0-2 performance status
- Biochemical values within the following range
- Serum creatinine <2x upper limit of normal
Key exclusion criteria (11 listed)
- Allergy to tetracycline or minocycline
- Uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection
- Active systemic bacterial, fungal, or viral infection
- Concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis
- Pregnant or breast feeding
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 |
|---|---|---|
| TigecyclineAlso: TygacilDosage Form: one-hour intravenous infusion Dosage levels, frequency, duration: (3-week cycles) * Level 1: 50 mg daily x 10 doses; 1 week rest * Level 2: 100 mg daily x 10 doses; 1 week rest * Level 3: 150 mg daily x 10 doses; 1 week rest * Level 4: 200 mg daily x 10 doses 1 week rest * Level 5: 250 mg daily x 10 doses; 1 week rest * Level 6: 300 mg daily x 10 doses; 1 week rest * Level 7: 350 mg daily x 10 doses; 1 week rest | Drug | Tigecycline |
Primary outcome
Toxicity evaluated according to CTCAE version 4.03
Time frame: Reviewed at each visit and assessed at the end of each 3-week cycle
1 secondary outcome
Response rate assessment of tigecycline through laboratory assessments
Time frame: Assessed at the end of each 3-week cycle for the study duration
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 15 Apr 2015.
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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 study director
University Health Network, Toronto
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tigecycline in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 3 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 9 inclusion and 11 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Toxicity evaluated according to CTCAE version 4.03 (time frame: Reviewed at each visit and assessed at the end of each 3-week cycle). 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 15 Apr 2015.