Acute Myelogenous LeukemiaPhase 1NCT01090167
A Study of Clofarabine in Japanese Patients With Acute Myeloid Leukemia (AML)
A Phase 1 study testing clofarabine in people with Acute Myelogenous Leukemia, run by Genzyme, a Sanofi Company at 6 sites in Japan.
Trial summary
This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) at 20, 30, and 40 mg/m2/day on a… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Acute Myelogenous 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
- 14 participants
- Where
- 6 sitesJapan
- Study dates
- Feb 2010to Apr 2011
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having diagnosis of relapsed or refractory Acute Myeloid Leukemia (AML) according to the World Health Organization (WHO) criteria or untreated AML patients (60 years to 74 years) for whom standard induction chemotherapy is unlikely to be of benefit as judged by the investigator (or co-investigator)
- Age at the time of informed consent 20 years up to 74 years; 60 years or older for patients with previously untreated AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Be able to comply with the study procedures and follow-up examinations specified in this protocol.
- Hepatic, renal, pancreatic, and cardiac function satisfying the laboratory values criteria
Who cannot join
- Patients having diagnosis of acute promyelocytic leukemia(APL, French-American-British classification M3 or WHO classification of APL with t(15;17)(q22;q12), (PML/RARA and variants)
- Have had prior hematologic stem cell transplant
- Have had prior external beam radiation therapy to the pelvis
- Have systemic fungal, bacterial, viral, or other infection that cannot be controlled and is exhibiting symptoms related to the infection despite appropriate treatment. In addition, patients must have a temperature less than 38.0 for at least 48 hours prior to the first dose of the study drug.
- Have any other severe concurrent disease that is difficult to control by drug therapies, or have a history of serious organ dysfunction or disease involving the liver, kidney, pancreas, heart, or other organ system that may place the patient at undue risk
- Diagnosis of another malignancy, unless the patient meets none of the following conditions: 1) Any persisting treatment-related adverse events; 2) Less than 180 days of disease-free duration counted during the period from the treatment completion to enrollment; note that the patients meeting any of the following conditions is eligible:
Show all 18Show fewer
- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia are eligible for this study if treatment for the condition has been completed.
- Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
- Have a prior positive test for HBs antigen or antibody, HBc antibody, HCV antibody, or HIV antigen or antibody; note that the patients who have had treatment of vaccine and positive for HBs antibody is eligible.
- Have a clinically significant arrhythmia at screening or a known family history of QT prolongation. Marked prolongation of QTc interval exceeding 450 msec is considered clinically significant
- Have clinical evidence suggestive of central nervous system (CNS) involvement with leukemia
- Have a Psychiatric disorders that would interfere with consent, study participation, or follow-up
- Have had prior treatment with the study drug
- Have had any other chemotherapy or investigational agent received within 30 days prior to the first dose of the study drug
- If received any chemotherapy or investigational agent prior to this time point, drug-related adverse events must be recovered to the baseline value or Grade 1 or less prior to the first dose of the study drug (except for alopecia, and nail changes).
- Is currently participating in another concurrent investigational protocol
- Are pregnant or lactating.
- Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy during the study period and for six months after the last dose of study drug.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Nagoya Daini Red Cross Hospital
Aichi
National Hospital Organization Nagoya Medical Center
Aichi
University of Fukui Hospital
Fukui
Tokai University Hospital
Kanagawa
Jichi Medical University Hospital
Tochigi
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo
About this study
Official title: A Phase I, Open-label, Multi-center Study of Clofarabine (JC0707) in Japanese Patients With Acute Myeloid Leukemia (AML)
This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.
Read the detailed description
This is a Phase I, open-label, multi-center study of Clofarabine administered to Japanese patients with Acute Myeloid Leukemia (AML) who are relapsed/refractory or elderly untreated AML for whom standard induction chemotherapy is unlikely to be of benefit.
Cohort 1 will receive 20 mg/m2/day of Clofarabine once daily for five consecutive days, Cohort 2 will receive 30 mg/m2/day, and Cohort 3 will receive 40 mg/m2/day. Patients will receive one cycle as a rule. However, if there is evidence of some hematologic response after one cycle of treatment with Clofarabine, patients may receive up to a maximum of three cycles. If patients fail to achieve CR or CRp after two cycles of treatment with Clofarabine, further dosing for such patients should be stopped.
Three patients constituting a cohort will receive Clofarabine and will then be assessed for dose limiting toxicities (DLT) at Cycle 1. If none of these three patients develops DLT, the next cohort will be introduced. If one of them develops DLT, three new patients will be added to the cohort, so that six patients in total are included in the tolerability assessment. In this case, treatment of the next cohort is allowed only in the case the number of patients who develop DLT is still one in this six-patient cohort. If two of the six patients develop DLT, however, the tolerability is ruled out. However, if two DLTs are observed at the 20mg/m2/day dose cohort, new patients will be enrolled at cohort -1 15mg/m2/day; and if no more than one of six patients in the cohort develop DLT, it will be considered as the last cohort for this study.
- Conditions
- Acute Myelogenous Leukemia
- Being tested
- clofarabine
- 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 Evoltra, Clolar, JC0707
Intravenous, 20 mg/m2, 30 mg/m2, 40 mg/m2
| 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.
Maximum Tolerated Dose (MTD) as determined by Dose Limiting Toxicities (DLTs)
Measured: 28 days (1st cycle)
Safety as measured by number of patients with at least one adverse events (incidence)
Measured: 50 days
Safety as measured by severity of adverse events
Measured: 50 days
Safety as measured by duration of adverse events
Measured: 50 days
Safety as measured by causality of adverse events
Measured: 50 days
Safety as measured by seriousness of adverse events
Measured: 50 days
Safety as measured by type of adverse event
Measured: 50 days
Safety as measured by number of deaths
Measured: 50 days
Safety as measured by number of serious adverse events
Measured: 50 days
Safety as measured by number of patients who discontinue due to adverse events
Measured: 50 days
Safety as measured by clinically significant changes in hematology
Measured: 50 days
Safety as measured by clinically significant changes in chemistry parameters (i.e. serum chemistry)
Measured: 50 days
Pharmacokinetic (PK) parameters (Cmax, Tmax, AUC)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090167
- Sponsor's protocol ID
- CLOAML10508
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2010
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 I, Open-label, Multi-center Study of Clofarabine (JC0707) in Japanese Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01090167
- Acronym / sponsor ID
- CLOAML10508
- Conditions
- Acute Myelogenous Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Mar 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.
This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.
Detailed description
This is a Phase I, open-label, multi-center study of Clofarabine administered to Japanese patients with Acute Myeloid Leukemia (AML) who are relapsed/refractory or elderly untreated AML for whom standard induction chemotherapy is unlikely to be of benefit.
Cohort 1 will receive 20 mg/m2/day of Clofarabine once daily for five consecutive days, Cohort 2 will receive 30 mg/m2/day, and Cohort 3 will receive 40 mg/m2/day. Patients will receive one cycle as a rule. However, if there is evidence of some hematologic response after one cycle of treatment with Clofarabine, patients may receive up to a maximum of three cycles. If patients fail to achieve CR or CRp after two cycles of treatment with Clofarabine, further dosing for such patients should be stopped.
Three patients constituting a cohort will receive Clofarabine and will then be assessed for dose limiting toxicities (DLT) at Cycle 1. If none of these three patients develops DLT, the next cohort will be introduced. If one of them develops DLT, three new patients will be added to the cohort, so that six patients in total are included in the tolerability assessment. In this case, treatment of the next cohort is allowed only in the case the number of patients who develop DLT is still one in this six-patient cohort. If two of the six patients develop DLT, however, the tolerability is ruled out. However, if two DLTs are observed at the 20mg/m2/day dose cohort, new patients will be enrolled at cohort -1 15mg/m2/day; and if no more than one of six patients in the cohort develop DLT, it will be considered as the last cohort for this study.
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: clofarabine |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients having diagnosis of relapsed or refractory Acute Myeloid Leukemia (AML) according to the World Health Organization (WHO) criteria or untreated AML patients (60 years to 74 years) for whom standard induction chemotherapy is unlikely to be of benefit as judged by the investigator (or co-investigator)
- Age at the time of informed consent 20 years up to 74 years; 60 years or older for patients with previously untreated AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Be able to comply with the study procedures and follow-up examinations specified in this protocol.
- Hepatic, renal, pancreatic, and cardiac function satisfying the laboratory values criteria
Key exclusion criteria (18 listed)
- Patients having diagnosis of acute promyelocytic leukemia(APL, French-American-British classification M3 or WHO classification of APL with t(15;17)(q22;q12), (PML/RARA and variants)
- Have had prior hematologic stem cell transplant
- Have had prior external beam radiation therapy to the pelvis
- Have systemic fungal, bacterial, viral, or other infection that cannot be controlled and is exhibiting symptoms related to the infection despite appropriate treatment. In addition, patients must have a temperature less than 38.0 for at least 48 hours prior to the first dose of the study drug.
- Have any other severe concurrent disease that is difficult to control by drug therapies, or have a history of serious organ dysfunction or disease involving the liver, kidney, pancreas, heart, or other organ system that may place the patient at undue risk
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: Evoltra, Clolar, JC0707Intravenous, 20 mg/m2, 30 mg/m2, 40 mg/m2 | Drug | Clofarabine |
Primary outcome
Maximum Tolerated Dose (MTD) as determined by Dose Limiting Toxicities (DLTs)
Time frame: 28 days (1st cycle)
Safety as measured by number of patients with at least one adverse events (incidence)
Time frame: 50 days
Safety as measured by severity of adverse events
Time frame: 50 days
Safety as measured by duration of adverse events
Time frame: 50 days
Safety as measured by causality of adverse events
Time frame: 50 days
Safety as measured by seriousness of adverse events
Time frame: 50 days
Safety as measured by type of adverse event
Time frame: 50 days
Safety as measured by number of deaths
Time frame: 50 days
Safety as measured by number of serious adverse events
Time frame: 50 days
Safety as measured by number of patients who discontinue due to adverse events
Time frame: 50 days
Safety as measured by clinically significant changes in hematology
Time frame: 50 days
Safety as measured by clinically significant changes in chemistry parameters (i.e. serum chemistry)
Time frame: 50 days
Pharmacokinetic (PK) parameters (Cmax, Tmax, AUC)
Time frame: 6 days
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.
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing clofarabine in people with Acute Myelogenous Leukemia, run by Genzyme, a Sanofi Company at 6 sites in Japan.
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 5 inclusion and 18 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 6 sites in Japan. 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 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 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?
Maximum Tolerated Dose (MTD) as determined by Dose Limiting Toxicities (DLTs) (time frame: 28 days (1st cycle)). The study lists 13 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 19 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.