Acute Myeloid LeukemiaPhase 1NCT01065545
The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
A Phase 1 study testing Clofarabine in people with Acute Myeloid Leukemia, run by Northwestern University.
Trial summary
The purpose of this study is to determine the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (AML), in remission. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Clofarabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to not given
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukemia, in first or second remission.
- Age 55 or older
- Patients must have given signed, informed consent prior to registration on study.
- Participants must have attained a complete remission (CR) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant.
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Who cannot join
- Patients with a diagnosis of acute promyelocytic leukemia are not eligible.
- Participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy.
- Patients must not be receiving any other investigational agents.
- Participants cannot have Hepatitis B or C or HIV.
- Patients must not have an uncontrolled infection
About this study
Official title: A Phase I Feasibility Study Assessing the Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
The purpose of this study is to determine the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (AML), in remission.
Read the detailed description
Standard induction chemotherapy (chemotherapy given with the intent of inducing a remission/disappearance of the cancer) can lead to a complete remission (CR) in a large percentage (60% to 80%) of younger patients with newly diagnosed AML. However, the majority of patients relapse (their disease returns) despite intensive consolidation chemotherapy. In most chemotherapy studies, only a small percentage (30% to 40%) of patients who achieve a CR still are disease-free 5 years later. The outcome for older adults is even less favorable. Approximately 75% of elderly patients who achieve CR will relapse after 2 years or less and the toxicities seen with treatment are significant. A number of studies have shown that chemotherapy given to older adults after a remission has not improved this outcome; therefore new treatments need to be investigated. Clofarabine is a drug that has been studied in older adults who have achieved a CR. The treatment was found to have fewer side effects then other consolidation therapies. This study will give participants the drug for a longer period of time to see if doing this will extend the cancer remission. Clofarabine has been approved by the FDA for the treatment of acute lymphoblastic leukemia (ALL), another form of acute leukemia. The study drug is considered experimental for AML because it has not been approved by the Food and Drug Administration (FDA) for the treatment of AML.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Clofarabine
- Keywords
- 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.
ClofarabineDrug
Also called CLOLAR, CAFda, Cl-F-ara-A
dose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days)
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | Not described Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of oral clofarabine.
Measured: at study completion (estimated at 2 years)
Secondary outcomes (1)
Measure the relapse-free survival.
Measured: labs drawn weekly (first cycle) and every other week thereafter until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJun 2011
Why it stopped: Due to funding issues.
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 Northwestern UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University, Rush University Medical Center, University of Illinois Chicago, Genzyme, a Sanofi Company
- Investigators
- Jessica Altman, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065545
- Sponsor's protocol ID
- NU 08H6
- Other IDs
- STU00008055
- Status last verified
- Apr 2015
- First submitted
- 8 Feb 2010
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Study Assessing the Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01065545
- Acronym / sponsor ID
- NU 08H6
- Conditions
- Acute Myeloid Leukemia
- Keywords
- leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to funding issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Loyola University, Rush University Medical Center, University of Illinois Chicago, Genzyme, a Sanofi Company
- Study start
- Jun 2011
- First posted
- 9 Feb 2010 (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 the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (AML), in remission.
Detailed description
Standard induction chemotherapy (chemotherapy given with the intent of inducing a remission/disappearance of the cancer) can lead to a complete remission (CR) in a large percentage (60% to 80%) of younger patients with newly diagnosed AML. However, the majority of patients relapse (their disease returns) despite intensive consolidation chemotherapy. In most chemotherapy studies, only a small percentage (30% to 40%) of patients who achieve a CR still are disease-free 5 years later. The outcome for older adults is even less favorable. Approximately 75% of elderly patients who achieve CR will relapse after 2 years or less and the toxicities seen with treatment are significant. A number of studies have shown that chemotherapy given to older adults after a remission has not improved this outcome; therefore new treatments need to be investigated. Clofarabine is a drug that has been studied in older adults who have achieved a CR. The treatment was found to have fewer side effects then other consolidation therapies. This study will give participants the drug for a longer period of time to see if doing this will extend the cancer remission. Clofarabine has been approved by the FDA for the treatment of acute lymphoblastic leukemia (ALL), another form of acute leukemia. The study drug is considered experimental for AML because it has not been approved by the Food and Drug Administration (FDA) for the treatment of AML.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine | Experimental | Drug: Clofarabine |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of acute myeloid leukemia, in first or second remission.
- Age 55 or older
- Patients must have given signed, informed consent prior to registration on study.
- Participants must have attained a complete remission (CR) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant.
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Key exclusion criteria (5 listed)
- Patients with a diagnosis of acute promyelocytic leukemia are not eligible.
- Participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy.
- Patients must not be receiving any other investigational agents.
- Participants cannot have Hepatitis B or C or HIV.
- Patients must not have an uncontrolled infection
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 |
|---|---|---|
| ClofarabineAlso: CLOLAR, CAFda, Cl-F-ara-Adose escalation, administered orally, once a day for 21 days per cycle (cycles begin every 28-49 days) | Drug | Clofarabine |
Primary outcome
Determine the maximum tolerated dose of oral clofarabine.
Time frame: at study completion (estimated at 2 years)
1 secondary outcome
Measure the relapse-free survival.
Time frame: labs drawn weekly (first cycle) and every other week thereafter until progression
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
Jessica Altman, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clofarabine in people with Acute Myeloid Leukemia, run by Northwestern University.
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 5 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: withdrawn, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the maximum tolerated dose of oral clofarabine. (time frame: at study completion (estimated at 2 years)). 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 10 Apr 2015.