Acute Myeloid LeukemiaPhase 2NCT00273884
Amonafide in Combination With Cytarabine in Secondary AML
A Phase 2 study testing Amonafide L-Malate and Cytarabine in people with Acute Myeloid Leukemia, run by Xanthus Pharmaceuticals, Inc. at 21 sites in 2 countries.
Trial summary
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML. 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?
- Amonafide L-Malate and Cytarabine
- How many people
- 80 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Aug 2005to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of AML (≥20% blasts of myeloid lineage in bone marrow), with FAB classification other than M3, secondary to either:
- Known and documented exposure to prior leukemogenic chemotherapy or radiotherapy, OR
- Diagnosis of MDS for ≥3 months prior to study entry (prior BM slides documenting MDS must be available for central pathology review).
- Age 18 years or older.
- ECOG performance status ≤2.
- No prior induction chemotherapy for AML; at least 4 weeks since completion of prior chemotherapy for MDS. (Subjects with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy).
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- Fertile and sexually active men and women must use effective contraception throughout study. Women of childbearing potential must have a negative pregnancy test.
- LVEF ≥50% by MUGA or ECHO.
- Adequate renal function: serum creatinine ≤1.5 x ULN.
- Adequate hepatic function: total serum bilirubin ≤1.5 x ULN as well as serum AST and ALT ≤1.5 x ULN.
- Subject must be able to participate fully in all aspects of the trial.
- Subject must give voluntary, written consent and HIPAA authorization (US only).
Who cannot join
- Histologic diagnosis of FAB M3 AML (acute promyelocytic leukemia).
- Clinically active CNS leukemia.
- Known to be HIV positive.
- Prior induction chemotherapy for AML.
- Known active hepatitis B or C or other active liver disease.
- Any major surgery or radiation therapy within 4 weeks prior to study entry.
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- Prior cytotoxic chemotherapy within 4 weeks prior to study entry.(Subjects with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy).
- Persistent chronic non-hematologic toxicity from prior chemotherapy (other than alopecia) that is > than grade 1.
- Serious concomitant illness (e.g., active pulmonary infection, unstable angina or myocardial infarction within 3 months of study entry, congestive heart failure ≥AHA class 2, stroke within 3 months prior to study entry, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.).
- Women who are pregnant or lactating.
- History of clinically significant allergic reactions attributed to compounds similar to amonafide or cytarabine.
- Prior enrollment on this trial.
- Any other known condition (familial, sociological, or geographic) or behavior (including substance abuse, psychological or psychiatric illness), which in the investigator's opinion would make the subject a poor candidate for this trial.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48109-0848
University of Colorado Health Sciences Center, Anschutz Cancer Center
Aurora, Colorado, 80010
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 75246
MUSC - Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Baylor University Medical Center
Dallas, Texas, 75246
City of Hope National Medical Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida Health Science Center
Gainesville, Florida, 32610-0277
St. Francis Cancer Research Foundation (formerly Indiana Oncology Hematology Consultants and American Health Network of Indiana LLC, Oncology Division)
Indianapolis, Indiana, 46202
UCLA Medical Center
Los Angeles, California, 90024
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University Medical Center
Morgantown, West Virginia, 26506-9162
University of Nebraska Medical Center
Omaha, Nebraska, 98198 7835
Scripps Cancer Center
San Diego, California, 92121
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Canada2 sites
London Regional Cancer Program, London Health Science Center
London, Ontario, N6A 4L6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E3
About this study
Official title: Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia (AML)
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
Read the detailed description
This is a two-stage, open-label, phase 2, multicenter study of amonafide L-malate in combination with standard-dose cytarabine in subjects with secondary AML.
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. In three phase I clinical trials, amonafide demonstrated anti-leukemic activity, both as monotherapy and in combination with cytarabine. This protocol is designed to further assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
The duration of the study is approximately 42 months: enrollment approximately 18 months and subject duration up to 24 months
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Amonafide L-Malate, Cytarabine
- Keywords
- AML, Secondary AML, Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amonafide L-MalateDrug
CytarabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi).
Secondary outcomes (7)
Determine the median duration of complete remission with or without complete hematopoietic recovery (CR or CRi)
Determine the proportion of subjects remaining in complete remission (CR +CRi) at 6 months, at 12 months and at 18 months
Determine the median duration of overall survival (OS)
Correlate clinical responses and duration of responses with specific cytogenetic abnormalities
Define the population pharmacokinetic (PK) profile of amonafide and its metabolites when administered as an intravenous infusion daily x 5 days in combination with a standard-dose of cytarabine
Define the safety profile and confirm the acceptability of amonafide and cytarabine
Correlate PK exposure of amonafide and acetylation of amonafide with safety and efficacy assessments in individual subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startAug 2005
- Study completionApr 2009
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Xanthus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Allen, MD, Principal investigator, North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273884
- Sponsor's protocol ID
- 0001A3-200-GL
- Status last verified
- Feb 2007
- First submitted
- 5 Jan 2006
- Last updated
- 19 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT00273884
- Acronym / sponsor ID
- 0001A3-200-GL
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Secondary AML, Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Xanthus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Apr 2009
- First posted
- 9 Jan 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.
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
Detailed description
This is a two-stage, open-label, phase 2, multicenter study of amonafide L-malate in combination with standard-dose cytarabine in subjects with secondary AML.
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. In three phase I clinical trials, amonafide demonstrated anti-leukemic activity, both as monotherapy and in combination with cytarabine. This protocol is designed to further assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
The duration of the study is approximately 42 months: enrollment approximately 18 months and subject duration up to 24 months
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)
- Histologic diagnosis of AML (≥20% blasts of myeloid lineage in bone marrow), with FAB classification other than M3, secondary to either:
- Age 18 years or older.
- ECOG performance status ≤2.
- No prior induction chemotherapy for AML; at least 4 weeks since completion of prior chemotherapy for MDS. (Subjects with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy).
- Fertile and sexually active men and women must use effective contraception throughout study. Women of childbearing potential must have a negative pregnancy test.
Key exclusion criteria (13 listed)
- Histologic diagnosis of FAB M3 AML (acute promyelocytic leukemia).
- Clinically active CNS leukemia.
- Known to be HIV positive.
- Prior induction chemotherapy for AML.
- Known active hepatitis B or C or other active liver disease.
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 |
|---|---|---|
| Amonafide L-Malate | Drug | – |
| Cytarabine | Drug | – |
Primary outcome
- To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi).
7 secondary outcomes
Determine the median duration of complete remission with or without complete hematopoietic recovery (CR or CRi)
Determine the proportion of subjects remaining in complete remission (CR +CRi) at 6 months, at 12 months and at 18 months
Determine the median duration of overall survival (OS)
Correlate clinical responses and duration of responses with specific cytogenetic abnormalities
Define the population pharmacokinetic (PK) profile of amonafide and its metabolites when administered as an intravenous infusion daily x 5 days in combination with a standard-dose of cytarabine
Define the safety profile and confirm the acceptability of amonafide and cytarabine
Correlate PK exposure of amonafide and acetylation of amonafide with safety and efficacy assessments in individual subjects
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 19 Feb 2007.
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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.
Steven Allen, MD principal investigator
North Shore Hospital
21 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 Amonafide L-Malate and Cytarabine in people with Acute Myeloid Leukemia, run by Xanthus Pharmaceuticals, Inc. at 21 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 12 inclusion and 13 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 19 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 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?
- To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi).. 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 19 Feb 2007.