Myelodysplastic SyndromePhase 2NCT00422032
2 Arm Study of Clofarabine IV in MDS Patients
A Phase 2 study testing Clofarabine in people with Myelodysplastic Syndrome and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myelodysplastic Syndrome, 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS) risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).
- No prior intensive chemotherapy or high-dose ara-C (> 1g/m2).
- Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
- Hydroxyurea is permitted for control of counts prior to treatment.
- Procrit, GCSF are allowed before therapy.
- Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function including the following: Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 * upper limit of normal (ULN). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded).
- Signed informed consent.
Who cannot join
- Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Active and uncontrolled infections.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Prior clofarabine treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Study of Two Different Schedules of Intravenous Clofarabine in Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.
Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.
Secondary Objective: Compare response durations, survivals and side effects of the two schedules.
Read the detailed description
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups (Groups A and B). Participants in Group A will receive a lower dose of clofarabine. Participants in Group B will receive a higher dose of clofarabine. At first, there will be an equal chance of being assigned to either group. However, as experience increases and more information becomes available, the chance of being assigned to the group that has shown the most effectiveness will increase. You and the study doctor will know to which group you are assigned.
Participants will receive clofarabine as a 1-hour infusion into a vein once a day for 5 days in a row. This will be repeated every 4 to 8 weeks. Each 4-8 week period is considered 1 cycle of treatment.
For participants in both groups, after each cycle of therapy, they will not receive the next cycle of chemotherapy until their blood counts have recovered and any possible side effects have gone away (for around 4 to 8 weeks). You must stay in Houston for the first treatment cycle (about 4 to 8 weeks) and will be required to return to Houston before receiving each additional cycle of chemotherapy (up to 6 days each cycle).
Before every treatment cycle, your doctor will perform a physical exam, including measurement of your weight and vital signs (blood pressure, heart rate, temperature, and breathing rate). You will be asked about the level of your daily activities and how you are feeling. You will have blood samples (about 1-2 teaspoons) collected for routine lab tests 1-2 times a week for the first cycle, then every 2-4 weeks while on therapy. Repeat bone marrow samples will be collected every 1-3 cycles. However, if you complete the study before the third cycle, the bone marrow may be taken then. You may choose to have check-up visits and blood tests with your local doctor.
If you show a response and do not experience any severe side effects, you can receive up to a total of 12 cycles of therapy. During each cycle, clofarabine will be given the same way as during the first cycle. However, the dose of clofarabine may be lowered during later cycles to decrease the risk of side effects that may have occurred in previous cycles. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
This is an investigational study. Clofarabine is approved by the FDA for treatment of pediatric acute lymphoblastic leukemia. Its use in this study is experimental. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Myelodysplastic Syndrome, Leukemia
- Being tested
- Clofarabine
- Keywords
- Myelodysplastic Syndrome, Leukemia, Clofarabine, MDS
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofarabineDrug
Also called Clolar
Group A: 15 mg/m^2 IV over 1 hour daily for 5 days
Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 15 mg/m^2 Clofarabine | Experimental | Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days Receives: Drug: Clofarabine |
| 30 mg/m^2 Clofarabine | Experimental | Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response for Two Dose Schedules of Clofarabine
Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts </=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to >/= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).
Measured: 4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2011
- Study completionNov 2011
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 Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Hagop Kantarjian, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422032
- Sponsor's protocol ID
- 2005-0535
- Status last verified
- Jun 2012
- First submitted
- 11 Jan 2007
- Last updated
- 27 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Two Different Schedules of Intravenous Clofarabine in Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00422032
- Acronym / sponsor ID
- 2005-0535
- Conditions
- Myelodysplastic Syndrome, Leukemia
- Keywords
- Myelodysplastic Syndrome, Leukemia, Clofarabine, MDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jan 2006
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Posted 27 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.
Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.
Secondary Objective: Compare response durations, survivals and side effects of the two schedules.
Detailed description
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups (Groups A and B). Participants in Group A will receive a lower dose of clofarabine. Participants in Group B will receive a higher dose of clofarabine. At first, there will be an equal chance of being assigned to either group. However, as experience increases and more information becomes available, the chance of being assigned to the group that has shown the most effectiveness will increase. You and the study doctor will know to which group you are assigned.
Participants will receive clofarabine as a 1-hour infusion into a vein once a day for 5 days in a row. This will be repeated every 4 to 8 weeks. Each 4-8 week period is considered 1 cycle of treatment.
For participants in both groups, after each cycle of therapy, they will not receive the next cycle of chemotherapy until their blood counts have recovered and any possible side effects have gone away (for around 4 to 8 weeks). You must stay in Houston for the first treatment cycle (about 4 to 8 weeks) and will be required to return to Houston before receiving each additional cycle of chemotherapy (up to 6 days each cycle).
Before every treatment cycle, your doctor will perform a physical exam, including measurement of your weight and vital signs (blood pressure, heart rate, temperature, and breathing rate). You will be asked about the level of your daily activities and how you are feeling. You will have blood samples (about 1-2 teaspoons) collected for routine lab tests 1-2 times a week for the first cycle, then every 2-4 weeks while on therapy. Repeat bone marrow samples will be collected every 1-3 cycles. However, if you complete the study before the third cycle, the bone marrow may be taken then. You may choose to have check-up visits and blood tests with your local doctor.
If you show a response and do not experience any severe side effects, you can receive up to a total of 12 cycles of therapy. During each cycle, clofarabine will be given the same way as during the first cycle. However, the dose of clofarabine may be lowered during later cycles to decrease the risk of side effects that may have occurred in previous cycles. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
This is an investigational study. Clofarabine is approved by the FDA for treatment of pediatric acute lymphoblastic leukemia. Its use in this study is experimental. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 mg/m^2 Clofarabine | Experimental | Drug: ClofarabineLower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days |
| 30 mg/m^2 Clofarabine | Experimental | Drug: ClofarabineHigher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS) risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).
- No prior intensive chemotherapy or high-dose ara-C (> 1g/m2).
- Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
- Hydroxyurea is permitted for control of counts prior to treatment.
Key exclusion criteria (4 listed)
- Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Active and uncontrolled infections.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Prior clofarabine 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 |
|---|---|---|
| ClofarabineAlso: ClolarGroup A: 15 mg/m^2 IV over 1 hour daily for 5 days Group B: 30 mg/m^2 IV over 1 hour daily for 5 days | Drug | 15 mg/m^2 Clofarabine, 30 mg/m^2 Clofarabine |
Primary outcome
Number of Participants With Response for Two Dose Schedules of Clofarabine
Time frame: 4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)
Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts </=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to >/= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M.D. Anderson's WebsiteLink provided by the sponsor.
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Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
Hagop Kantarjian, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 in people with Myelodysplastic Syndrome and Leukemia, run by M.D. Anderson Cancer Center at 1 site 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 8 inclusion and 4 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 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 27 Jul 2012). 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?
Number of Participants With Response for Two Dose Schedules of Clofarabine (time frame: 4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)). 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 27 Jul 2012.