Acute Myelogenous LeukemiaPhase 2NCT00044889
Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
A Phase 2 study testing clofarabine (IV formulation) in people with Acute Myelogenous Leukemia, run by Genzyme, a Sanofi Company at 12 sites in United States.
Trial summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. 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?
- clofarabine (IV formulation)
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2002to Mar 2003
- 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
- note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
- Diagnosis of AML according to FAB classification
- Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
- A Karnofsky Performance Status (KPS) of greater than or equal to 60.
- If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
- Signed, written informed consent.
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- Ability to comply with study procedures and follow-up examinations.
- Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration.
- Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.
Who cannot join
- note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
- Received previous treatment with CLOFARABINE.
- Received more than two previous induction regimens or cycles for the treatment of AML.
- Relapsed > 1 year.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
- Are pregnant or lactating.
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- Have psychiatric disorders that would interfere with consent, study participation or follow-up.
- Are receiving any other chemotherapy or corticosteroids. Patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment.
- Have any other severe concurrent disease.
- Have symptomatic CNS involvement.
- Have chronic myelogenous leukemia (CML) in lymphoid blast crisis).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Buffalo, New York
Study site
Chicago, Illinois
Study site
Durham, North Carolina
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Norfolk, Virginia
Study site
Omaha, Nebraska
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Washington D.C., District of Columbia
About this study
Official title: A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed < one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- clofarabine (IV formulation)
- Keywords
- CLO221, clolar
- 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.
clofarabine (IV formulation)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2002 (estimated)
- Study startMay 2002
- Study completionMar 2003
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044889
- Sponsor's protocol ID
- CLO221
- Status last verified
- Mar 2014
- First submitted
- 6 Sep 2002
- Last updated
- 19 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00044889
- Acronym / sponsor ID
- CLO221
- Conditions
- Acute Myelogenous Leukemia
- Keywords
- CLO221, clolar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Mar 2003 (actual)
- First posted
- 9 Sep 2002 (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.
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed < one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.
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 (9 listed)
- note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
- Diagnosis of AML according to FAB classification
- Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory
- A Karnofsky Performance Status (KPS) of greater than or equal to 60.
- If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
Key exclusion criteria (11 listed)
- note: For inclusion and exclusion criteria, a regimen is defined as including Induction, Consolidation, and Maintenance therapies.
- Received previous treatment with CLOFARABINE.
- Received more than two previous induction regimens or cycles for the treatment of AML.
- Relapsed > 1 year.
- Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
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 |
|---|---|---|
| clofarabine (IV formulation) | Drug | – |
Primary outcome
Not reported in the source record.
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 Mar 2014.
- US FDA Approved Full Prescribing Information for Clolar®Link provided by the sponsor.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clofarabine (IV formulation) in people with Acute Myelogenous Leukemia, run by Genzyme, a Sanofi Company at 12 sites 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 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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 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.
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 Mar 2014.