Acute Myelogenous LeukemiaPhase 1/2NCT00106600
Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)
A Phase 1/2 study testing Pixantrone IV infusion in people with Acute Myelogenous Leukemia, run by CTI BioPharma at 1 site in United States.
Trial summary
The goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an additional 86 patients will be enrolled. During this part of the study, the safety and effectiveness will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia
- What is being tested?
- Pixantrone IV infusion
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2007
- Phase
- Phase 1/2
- 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 morphologically confirmed diagnosis of relapsed AML with French-American-British (FAB) classification other than M3. Relapse should be demonstrated by the presence of greater than 5% leukemic blasts in the bone marrow or reappearance of greater than 5% leukemic blasts in the peripheral blood within 14 days of registration.
- Eligible patients include the following:
- Patients with secondary AML, including patients with prior myelodysplastic syndromes (MDS)
- Patients who were initially unresponsive to induction therapy
- Patients in first or second relapse from prior therapy or hematopoietic stem-cell transplant (HSCT)
- A period of at least 21 days must have elapsed from the completion of prior chemotherapy (with or without anthracyclines) and investigational agents to the first dose of treatment in this study, and all acute toxicities from prior therapy must have resolved (with the exception of alopecia).
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- Age >/= 18 years of age, and able to give informed consent.
- ECOG performance status of 0, 1 or 2.
- Bilirubin < 1.5 x institution's upper limit of normal (ULN), AST and ALT < 1.5 x institution's ULN, creatinine < 2 mg/dL.
- LVEF >/= 50% as measured by MUGA scan or 2-D ECHO within 14 days prior to registration. Either method is acceptable for measuring LVEF; however, the same method must be used throughout treatment and follow-up.
- Patients (male or female) of reproductive potential must commit to use adequate contraception (as defined by the investigator) during study treatment and for 6 months after the last day of study drug administration.
- Patients must have signed an approved informed consent prior to beginning protocol specific procedures
Who cannot join
- Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2 according to the following calculation index: X/450 + Y/160 < 1 where X is the doxorubicin dose in mg/m2 and Y is the mitoxantrone dose in mg/m2.
- Clinical or documented central nervous system (CNS) involvement with AML.
- Any uncontrolled active infection that requires antibiotics.
- History of Human Immunodeficiency Virus (HIV).
- Acute hepatitis, or known chronic hepatitis.
- Unstable cardiovascular conditions, including: cardiac arrhythmias, angina, or myocardial infarction within the past 6 months.
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- Pregnant women or nursing mothers.
- Prior malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years.
- Any condition which, in the judgment of the investigator, would place the patient at undue risk, interfere with the results of the study, or make the patient otherwise unsuitable.
- Any circumstance at the time of study entry that would preclude completion of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)
The goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an additional 86 patients will be enrolled. During this part of the study, the safety and effectiveness will be evaluated.
Read the detailed description
This is an open label, single center, phase I/II study of pixantrone in patients with refractory AML. Pixantrone will be administered for three consecutive days on days 1, 2 and 3 of each 21-day cycle, for up to two cycles.
The study has 2 parts; phase I and phase II. In the phase I part of the study, the maximum tolerated dose (MTD) for pixantrone as a single agent in patients with refractory AML will be determined. In the phase II part of the study, up to an additional 86 patients will be treated at the MTD to assess disease response.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- Pixantrone IV infusion
- Keywords
- Relapsed, Refractory
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pixantrone IV infusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: To determine the maximum tolerated dose (MTD) of Pixantrone (BBR 2778) in patients with refractory acute myelogenous leukemia (AML)
Phase II: To evaluate the activity of pixantrone in this patient population in terms of objective responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2005 (estimated)
- Study startMar 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106600
- Sponsor's protocol ID
- PIX109
- Status last verified
- Aug 2007
- First submitted
- 28 Mar 2005
- Last updated
- 18 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00106600
- Acronym / sponsor ID
- PIX109
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- Relapsed, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Mar 2007
- First posted
- 29 Mar 2005 (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 goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an additional 86 patients will be enrolled. During this part of the study, the safety and effectiveness will be evaluated.
Detailed description
This is an open label, single center, phase I/II study of pixantrone in patients with refractory AML. Pixantrone will be administered for three consecutive days on days 1, 2 and 3 of each 21-day cycle, for up to two cycles.
The study has 2 parts; phase I and phase II. In the phase I part of the study, the maximum tolerated dose (MTD) for pixantrone as a single agent in patients with refractory AML will be determined. In the phase II part of the study, up to an additional 86 patients will be treated at the MTD to assess disease response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with morphologically confirmed diagnosis of relapsed AML with French-American-British (FAB) classification other than M3. Relapse should be demonstrated by the presence of greater than 5% leukemic blasts in the bone marrow or reappearance of greater than 5% leukemic blasts in the peripheral blood within 14 days of registration.
- Patients with secondary AML, including patients with prior myelodysplastic syndromes (MDS)
- Patients who were initially unresponsive to induction therapy
- Patients in first or second relapse from prior therapy or hematopoietic stem-cell transplant (HSCT)
Key exclusion criteria (10 listed)
- Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2 according to the following calculation index: X/450 + Y/160 < 1 where X is the doxorubicin dose in mg/m2 and Y is the mitoxantrone dose in mg/m2.
- Clinical or documented central nervous system (CNS) involvement with AML.
- Any uncontrolled active infection that requires antibiotics.
- History of Human Immunodeficiency Virus (HIV).
- Acute hepatitis, or known chronic hepatitis.
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 |
|---|---|---|
| Pixantrone IV infusion | Drug | – |
Primary outcome
Phase I: To determine the maximum tolerated dose (MTD) of Pixantrone (BBR 2778) in patients with refractory acute myelogenous leukemia (AML)
Phase II: To evaluate the activity of pixantrone in this patient population in terms of objective responses
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 18 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pixantrone IV infusion in people with Acute Myelogenous Leukemia, run by CTI BioPharma at 1 site in United States.
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 12 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
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?
Phase I: To determine the maximum tolerated dose (MTD) of Pixantrone (BBR 2778) in patients with refractory acute myelogenous leukemia (AML). The study lists 2 primary outcomes in all. 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 18 Sep 2023.