Acute Myeloid LeukemiaPhase 2NCT00778375
Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Clofarabine, Cytarabine and Decitabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Clofarabine, Cytarabine and Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2015
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
- Age >/= 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 1.5 mg/dL).
- Sign written informed consent
Who cannot join
- Cardiac ejection fraction < 40%.
- Prior therapy with clofarabine or decitabine.
- Active and uncontrolled disease/infection as judged by the treating physician.
- Pregnancy
- Acute promyelocytic leukemia (APL).
- Women of childbearing potential and men who do not practice contraception.
- Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Clofarabine Plus Low-Dose Cytarabine Induction Followed by Consolidation of Clofarabine Plus Low-Dose Cytarabine Alternating With Decitabine in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.
Read the detailed description
The Study Drugs:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found eligible to take part in this study, on Days 1-5, you will receive clofarabine through a needle in your vein over 1-2 hours.
On Days 1-10, you will receive cytarabine by injection twice a day.
You may receive up to 2 cycles at this dose and schedule. There are 10 days in each cycle.
Consolidation Cycles:
If you show a response to the treatment, you can then continue with up to a total of 17 more cycles of therapy, which will be called "consolidation cycles". Not every participant may be able to receive all 17 consolidation cycles. The actual number that you will receive depends on whether or not you maintain the response and how you are able to tolerate ongoing therapy. There will be 4-7 weeks in between each consolidation cycle depending on any side effects you may be having and your blood counts.
For consolidation cycles 1, 2, 6, 7, 8, 12, 13, and 14, you will receive clofarabine and cytarabine, but the schedule will be different. On Days 1-3 you will receive clofarabine by vein. On Days 1-7, you will receive cytarabine by vein. On the days when you receive both clofarabine and cytarabine (Days 1-3), the clofarabine will be given about 3-6 hours before the cytarabine injections. You can be taught to give cytarabine injections to yourself. In this case, you can leave the clinic after receiving clofarabine. You will be required to record the injections of cytarabine in a diary unless you receive the treatments while you are in the hospital.
During consolidation cycles 3-5, 9-11, and 15-17, you will receive decitabine only. Decitabine will be given through a needle in your vein over 1-2 hours on Days 1-5. During the decitabine cycles, you may be treated at home, but must return to MD Anderson for study visits before the start of each cycle.
If you do not achieve a response after the first 2 cycles of treatment with clofarabine and cytarabine, you can stay on study and receive 3 cycles of decitabine alone (same dose and schedule as the consolidation course). If you achieve a response after the 3 decitabine cycles, you can continue with the consolidation cycles. If there is no evidence of response after the 3 decitabine cycles, you may be taken off study.
Study Visits:
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
About 3 weeks after your first course, you may have a bone marrow aspirate to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. After that, you will have a bone marrow aspirate every 2 weeks (or more often if your doctor feels it is necessary). If your routine blood tests indicate that there is still leukemia, you may not need to have the bone marrow samples collected.
You will need to stay in Houston for up to the first 5 weeks of treatment. After that, you will need to return to Houston before each cycle and to receive the clofarabine treatments. Decitabine-only consolidation cycles can be given by your local oncologist. In either case, you can have check-up visits and blood tests with your local doctor between treatments.
Length of Study:
You can stay on study for up to 19 cycles. You will be taken off study early if you experience any intolerable side effects. You may be taken off study early if the disease gets worse.
Follow-up Visits:
Once you are off active treatment but as long as you are still part of the study, every 3-6 months you will have blood (1 tablespoon) drawn to check the status of the disease and your overall health.
This is an investigational study. Clofarabine is FDA approved and commercially available for use in pediatric patients with ALL. Its use in patients with AML is experimental.
Cytarabine is FDA approved and commercially available for use in patients with AML.
Decitabine is FDA approved and commercially available for use in patients with MDS, but its use for patients with AML is investigational.
Up to 120 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- Clofarabine, Cytarabine, Decitabine
- Keywords
- Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, AML, MDS, Clofarabine, Ara-C, Cytarabine, Decitabine
- Medical subject headings
- Leukemia, Myeloid, Acute, 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®, Clorarex
20 mg/m^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days.
CytarabineDrug
Also called Cytosar-U®, Ara-C, Arabinosylcytosine
20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions.
DecitabineDrug
Also called Dacogen®
20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine + Cytarabine + Decitabine | Experimental | Clofarabine 20 mg/m^2 by vein (IV) as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days. Receives: Drug: Clofarabine; Drug: Cytarabine; Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free (DFS) or Relapse-free Survival (RFS) Time
Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.
Measured: Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.
Complete Remission (CR) Rate for First 60 Participants
All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.
Measured: Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days
Median Overall Survival (OS)
Overall survival (OS): Time from date of treatment start until date of death due to any cause.
Measured: Evaluated from treatment date until date of death, followed for 5 years/60 months.
Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]
All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.
Measured: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days
Secondary outcomes (2)
Event Free Survival (EFS)
EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.
Measured: Follow up up to 5 years/60 months.
Overall Response Rate (CR, CRp/CRi and PR)
IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.
Measured: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2015
- Study completionJan 2015
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc., Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Farhad Ravandi-Kashani, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778375
- Sponsor's protocol ID
- 2007-0039
- Other IDs
- NCI-2012-01622
- Status last verified
- Jun 2016
- First submitted
- 21 Oct 2008
- Last updated
- 14 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofarabine Plus Low-Dose Cytarabine Induction Followed by Consolidation of Clofarabine Plus Low-Dose Cytarabine Alternating With Decitabine in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00778375
- Acronym / sponsor ID
- 2007-0039
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Keywords
- Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, AML, MDS, Clofarabine, Ara-C, Cytarabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc., Genzyme, a Sanofi Company
- Study start
- Oct 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Posted 26 Feb 2016
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 learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.
Detailed description
The Study Drugs:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found eligible to take part in this study, on Days 1-5, you will receive clofarabine through a needle in your vein over 1-2 hours.
On Days 1-10, you will receive cytarabine by injection twice a day.
You may receive up to 2 cycles at this dose and schedule. There are 10 days in each cycle.
Consolidation Cycles:
If you show a response to the treatment, you can then continue with up to a total of 17 more cycles of therapy, which will be called "consolidation cycles". Not every participant may be able to receive all 17 consolidation cycles. The actual number that you will receive depends on whether or not you maintain the response and how you are able to tolerate ongoing therapy. There will be 4-7 weeks in between each consolidation cycle depending on any side effects you may be having and your blood counts.
For consolidation cycles 1, 2, 6, 7, 8, 12, 13, and 14, you will receive clofarabine and cytarabine, but the schedule will be different. On Days 1-3 you will receive clofarabine by vein. On Days 1-7, you will receive cytarabine by vein. On the days when you receive both clofarabine and cytarabine (Days 1-3), the clofarabine will be given about 3-6 hours before the cytarabine injections. You can be taught to give cytarabine injections to yourself. In this case, you can leave the clinic after receiving clofarabine. You will be required to record the injections of cytarabine in a diary unless you receive the treatments while you are in the hospital.
During consolidation cycles 3-5, 9-11, and 15-17, you will receive decitabine only. Decitabine will be given through a needle in your vein over 1-2 hours on Days 1-5. During the decitabine cycles, you may be treated at home, but must return to MD Anderson for study visits before the start of each cycle.
If you do not achieve a response after the first 2 cycles of treatment with clofarabine and cytarabine, you can stay on study and receive 3 cycles of decitabine alone (same dose and schedule as the consolidation course). If you achieve a response after the 3 decitabine cycles, you can continue with the consolidation cycles. If there is no evidence of response after the 3 decitabine cycles, you may be taken off study.
Study Visits:
On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a performance status evaluation.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
About 3 weeks after your first course, you may have a bone marrow aspirate to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. After that, you will have a bone marrow aspirate every 2 weeks (or more often if your doctor feels it is necessary). If your routine blood tests indicate that there is still leukemia, you may not need to have the bone marrow samples collected.
You will need to stay in Houston for up to the first 5 weeks of treatment. After that, you will need to return to Houston before each cycle and to receive the clofarabine treatments. Decitabine-only consolidation cycles can be given by your local oncologist. In either case, you can have check-up visits and blood tests with your local doctor between treatments.
Length of Study:
You can stay on study for up to 19 cycles. You will be taken off study early if you experience any intolerable side effects. You may be taken off study early if the disease gets worse.
Follow-up Visits:
Once you are off active treatment but as long as you are still part of the study, every 3-6 months you will have blood (1 tablespoon) drawn to check the status of the disease and your overall health.
This is an investigational study. Clofarabine is FDA approved and commercially available for use in pediatric patients with ALL. Its use in patients with AML is experimental.
Cytarabine is FDA approved and commercially available for use in patients with AML.
Decitabine is FDA approved and commercially available for use in patients with MDS, but its use for patients with AML is investigational.
Up to 120 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine + Cytarabine + Decitabine | Experimental | Drug: Clofarabine, Drug: Cytarabine, Drug: DecitabineClofarabine 20 mg/m^2 by vein (IV) as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
- Age >/= 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 1.5 mg/dL).
- Sign written informed consent
Key exclusion criteria (7 listed)
- Cardiac ejection fraction < 40%.
- Prior therapy with clofarabine or decitabine.
- Active and uncontrolled disease/infection as judged by the treating physician.
- Pregnancy
- Acute promyelocytic leukemia (APL).
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®, Clorarex20 mg/m^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days. | Drug | Clofarabine + Cytarabine + Decitabine |
| CytarabineAlso: Cytosar-U®, Ara-C, Arabinosylcytosine20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. | Drug | Clofarabine + Cytarabine + Decitabine |
| DecitabineAlso: Dacogen®20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days. | Drug | Clofarabine + Cytarabine + Decitabine |
Primary outcome
Disease-free (DFS) or Relapse-free Survival (RFS) Time
Time frame: Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.
Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.
Complete Remission (CR) Rate for First 60 Participants
Time frame: Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days
All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.
Median Overall Survival (OS)
Time frame: Evaluated from treatment date until date of death, followed for 5 years/60 months.
Overall survival (OS): Time from date of treatment start until date of death due to any cause.
Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]
Time frame: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days
All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.
2 secondary outcomes
Event Free Survival (EFS)
Time frame: Follow up up to 5 years/60 months.
Overall Response Rate (CR, CRp/CRi and PR)
Time frame: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Farhad Ravandi-Kashani, M.D. 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, Cytarabine and Decitabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, 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 5 inclusion and 7 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 14 Jul 2016. 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 26 Feb 2016). 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?
Disease-free (DFS) or Relapse-free Survival (RFS) Time (time frame: Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.). The study lists 4 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 14 Jul 2016.