Acute Myeloid LeukemiaPhase 2NCT00924443
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
A Phase 2 study testing clofarabine in people with Acute Myeloid Leukemia, run by Genzyme, a Sanofi Company at 15 sites in 3 countries.
Trial summary
The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- clofarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jun 2004to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provide signed, written informed consent
- Have untreated AML according to World Health Organization (WHO) classification
- Male or post-menopausal female ≥ 65 years of age
- Unsuitable for intensive chemotherapy
- Be able to comply with study procedures and follow-up examination
- Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
- Have adequate liver and renal function as indicated by certain laboratory values
Who cannot join
- Received previous treatment with clofarabine
- Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
- Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
- Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
- Have an active, uncontrolled systemic infection
- Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
- Have symptomatic central nervous system (CNS) involvement
- Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United Kingdom12 sites
Study site
Aberdeen
Study site
Belfast, Northern Ireland
Study site
Birmingham
Study site
Cardiff
Study site
Edinburgh
Study site
Leicester
Study site
Liverpool
Study site
London
Study site
Manchester
Study site
Nottingham
Study site
Somerset
Study site
Taunton
About this study
Official title: A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.
Read the detailed description
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- clofarabine
- Keywords
- acute myelogenous leukemia, acute myeloid leukemia, clolar, evoltra, clofarabine, untreated acute leukemia, adult acute leukemia
- 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.
clofarabineDrug
Also called tradename US = Clolar, tradename EU = Evoltra
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles. Receives: Drug: clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.
ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
Measured: At month 20
Secondary outcomes (4)
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.
Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
Measured: At month 20
Duration of Overall Response
Duration was calculated by Kaplan-Meier estimates
Measured: From 20 months up to 48 months
Overall Survival
Calculated by Kaplan-Meier estimates
Measured: From 20 months up to 48 months
Duration of Complete Remission
Duration was calculated by Kaplan- Meier estimates
Measured: From 20 months up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2004
- Primary completionJun 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioenvision
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924443
- Sponsor's protocol ID
- BIOV-121
- Status last verified
- Mar 2015
- First submitted
- 17 Jun 2009
- Last updated
- 1 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
- ClinicalTrials.gov ID
- NCT00924443
- Acronym / sponsor ID
- BIOV-121
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myelogenous leukemia, acute myeloid leukemia, clolar, evoltra, clofarabine, untreated acute leukemia, adult acute leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Bioenvision
- Study start
- Jun 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 1 Apr 2015
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 the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.
Detailed description
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine | Experimental | Drug: clofarabineClofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Provide signed, written informed consent
- Have untreated AML according to World Health Organization (WHO) classification
- Male or post-menopausal female ≥ 65 years of age
- Unsuitable for intensive chemotherapy
- Be able to comply with study procedures and follow-up examination
Key exclusion criteria (8 listed)
- Received previous treatment with clofarabine
- Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
- Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
- Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
- Have an active, uncontrolled systemic 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: tradename US = Clolar, tradename EU = Evoltra | Drug | Clofarabine |
Primary outcome
Overall Response Rate (ORR)
Time frame: At month 20
ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
4 secondary outcomes
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
Time frame: At month 20
Duration of Overall Response
Time frame: From 20 months up to 48 months
Overall Survival
Time frame: From 20 months up to 48 months
Duration of Complete Remission
Time frame: From 20 months up to 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clofarabine in people with Acute Myeloid Leukemia, run by Genzyme, a Sanofi Company at 15 sites in 3 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 7 inclusion and 8 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 1 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 15 sites in United Kingdom, Italy, Ireland. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) (time frame: At month 20). 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 1 Apr 2015.