LeukemiaPhase 1/2NCT01794702
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
A Phase 1/2 study testing Decitabine, Idarubicin and Cytarabine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Decitabine, Idarubicin and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2013to 11 Jan 2018
- Phase
- Phase 1/2
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sign an IRB-approved informed consent document.
- Age >/= 18 years and <65 years.
- Diagnosis of AML [other than acute promyelocytic leukemia] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed
- ECOG performance status of </=2 at study entry.
- Organ function as defined below (unless due to leukemia):Serum creatinine </= 3 mg/dL;Total bilirubin </= 2.5 mg/dL; ALT (SGPT) </= 3 x ULN or </= 5 x ULN if related to disease
- Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Who cannot join
- Breast feeding women
- Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
- Patients with active secondary malignancy will not be eligible unless approved by the PI.
- NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study
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: Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia
The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia.
The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied.
Read more
Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die.
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 6 participants will be enrolled in the Phase I portion of the study. Up to 74 participants will be enrolled in Phase II.
Phase I:
If you are enrolled in the Phase I portion, the number of days of clofarabine you receive will depend on when you joined this study. The first group of participants will receive clofarabine for 4 days. Each new group will receive clofarabine for the same number of days, if no intolerable side effects were seen. The number of days may be reduced to 3. The clofarabine dose per day is the same from group to group.
All participants will receive the same dose level of decitabine, idarubicin and cytarabine.
Phase II:
If you are enrolled in the Phase II portion, you will receive decitabine, idarubicin, and cytarabine. You will receive clofarabine for the highest number of days that was tolerated in the Phase I portion.
All participants will receive the same dose level of decitabine, idarubicin, cytarabine, and clofarabine.
Study Drug Administration:
Each study drug cycle is 33 days. The first cycle of study drugs is called Induction. If the doctor thinks it is needed, you will have up to 2 Induction cycles.
Phase I (Induction):
On Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1 hour.
On Days 6-10 of each cycle:
- You will receive cytarabine 1 time a day by vein over about 2 hours.
- On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.
- You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8 or 6-9, depending on when you join the study.
If the doctor thinks it is needed, your dose level will be reduced after Induction.
If the doctor thinks it is needed, you may receive fewer days of treatment in the Induction cycle(s).
Phase II (Induction):
On Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1 hour.
On Days 6-10 of each cycle:
- You will receive cytarabine 1 time a day by vein over about 2 hours.
- On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.
- You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8 or 6-9, depending on the highest number of days clofarabine was tolerated in the Phase I portion of the study.
If the doctor thinks it is needed, your dose level will be reduced after Induction.
If the doctor thinks it is needed, you may receive fewer days of treatment in the Induction cycle(s).
Phases I and II (Consolidation):
If the disease responds to the study drugs, you may receive up to 6 more study drug cycles. This is called Consolidation.
On Days 1-5 of each cycle:
°You will receive decitabine 1 time a day by vein over 1 hour.
On Days 6-8 of each cycle:
- You will receive cytarabine 1 time a day by vein over about 2 hours.
- You will receive clofarabine 1 time a day by vein over about 1 hour.
- On Days 6-7 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.
If the doctor thinks it is needed, you may receive fewer days of treatment in the Consolidation cycles.
Study Visits:
Before the start of each cycle, you will have a physical exam, including measurement of your vital signs.
Every 3-7 days, blood (about 2 teaspoons) will be drawn for routine tests.
On Day 33 of every 2-3 cycles (+/- 7 days), if the doctor thinks it is needed, you will 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.
Length of Treatment:
You may continue taking the study drugs for up to 8 cycles. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the long-term follow-up.
Long-term Follow-up:
Every 3 months for 1 year after your last study drug dose, the study staff will call you and ask how you are feeling, about any side effects you may be having, and about any other drugs you may be taking. These calls should last about 5 minutes each.
This is an investigational study. Decitabine is FDA approved and commercially available to treat myelodysplastic syndrome (MDS). Clofarabine is FDA approved and commercially available to treat ALL in children. Idarubicin and cytarabine are FDA approved and commercially available to treat AML. The study drug combination is investigational.
Up to 92 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Decitabine, Idarubicin, Cytarabine, Clofarabine
- Keywords
- Leukemia, Acute Leukemia, Acute myelogenous leukemia, AML, Acute lymphoblastic leukemia, ALL, Maximum Tolerated Dose, MTD, Response Rate, Decitabine, Dacogen, Idarubicin, Idamycin, Cytarabine, Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)
IdarubicinDrug
Also called Idamycin
Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)
CytarabineDrug
Also called Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)
ClofarabineDrug
Also called Clofarex, Clolar
Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9)
Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion).
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine + Cytarabine + Decitabine + Idarubicin | Experimental | Phase I - Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10)
Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour daily (number of days selected based on Phase I portion).
Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10) Receives: Drug: Decitabine; Drug: Idarubicin; Drug: Cytarabine; Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Clofarabine
Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).
Measured: After second, 33 day cycle
Number of Participants With a Response
Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.
Measured: 56 days
Secondary outcomes (2)
To Determine the Disease-free Survival (DFS).
Time from date of treatment start until the date of first objective documentation of return of disease.
Measured: Up to 2 years after participants off study date
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up.
Measured: Up to 2 years after participants off study date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study start20 Feb 2013
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
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 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 1/2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Starting with Dose level 1, the participants were enrolled by cohort of 3. Once the DLT assessment is completed, another cohort of 3 patients will be enrolled. If at any time, we see more than 30% patients experiencing DLT, we will de-escalate to dose level (-1). Period 1: Dose level 1 Clofarabine 15mg/m\^2 daily x 4 days (days 6-9) Period 2: Dose level-1 Clofarabine 15mg/m\^2 daily x 3 days (days 6-8)
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Jain, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794702
- Sponsor's protocol ID
- 2012-1064
- Other IDs
- NCI-2013-00548
- Status last verified
- May 2019
- First submitted
- 15 Feb 2013
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia
- ClinicalTrials.gov ID
- NCT01794702
- Acronym / sponsor ID
- 2012-1064
- Conditions
- Leukemia
- Keywords
- Leukemia, Acute Leukemia, Acute myelogenous leukemia, AML, Acute lymphoblastic leukemia, ALL, Maximum Tolerated Dose, MTD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Feb 2013 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 10 May 2019
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 Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia.
The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied.
Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die.
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of 6 participants will be enrolled in the Phase I portion of the study. Up to 74 participants will be enrolled in Phase II.
Phase I:
If you are enrolled in the Phase I portion, the number of days of clofarabine you receive will depend on when you joined this study. The first group of participants will receive clofarabine for 4 days. Each new group will receive clofarabine for the same number of days, if no intolerable side effects were seen. The number of days may be reduced to 3. The clofarabine dose per day is the same from group to group.
All participants will receive the same dose level of decitabine, idarubicin and cytarabine.
Phase II:
If you are enrolled in the Phase II portion, you will receive decitabine, idarubicin, and cytarabine. You will receive clofarabine for the highest number of days that was tolerated in the Phase I portion.
All participants will receive the same dose level of decitabine, idarubicin, cytarabine, and clofarabine.
Study Drug Administration:
Each study drug cycle is 33 days. The first cycle of study drugs is called Induction. If the doctor thinks it is needed, you will have up to 2 Induction cycles.
Phase I (Induction):
On Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1 hour.
On Days 6-10 of each cycle:
- You will receive cytarabine 1 time a day by vein over about 2 hours.
- On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.
- You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8 or 6-9, depending on when you join the study.
If the doctor thinks it is needed, your dose level will be reduced after Induction.
If the doctor thinks it is needed, you may receive fewer days of treatment in the Induction cycle(s).
Phase II (Induction):
On Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1 hour.
On Days 6-10 of each cycle:
- You will receive cytarabine 1 time a day by vein over about 2 hours.
- On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.
- You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8 or 6-9, depending on the highest number of days clofarabine was tolerated in the Phase I portion of the study.
If the doctor thinks it is needed, your dose level will be reduced after Induction.
If the doctor thinks it is needed, you may receive fewer days of treatment in the Induction cycle(s).
Phases I and II (Consolidation):
If the disease responds to the study drugs, you may receive up to 6 more study drug cycles. This is called Consolidation.
On Days 1-5 of each cycle:
°You will receive decitabine 1 time a day by vein over 1 hour.
On Days 6-8 of each cycle:
- You will receive cytarabine 1 time a day by vein over about 2 hours.
- You will receive clofarabine 1 time a day by vein over about 1 hour.
- On Days 6-7 only, you will receive idarubicin 1 time a day by vein over about 30 minutes.
If the doctor thinks it is needed, you may receive fewer days of treatment in the Consolidation cycles.
Study Visits:
Before the start of each cycle, you will have a physical exam, including measurement of your vital signs.
Every 3-7 days, blood (about 2 teaspoons) will be drawn for routine tests.
On Day 33 of every 2-3 cycles (+/- 7 days), if the doctor thinks it is needed, you will 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.
Length of Treatment:
You may continue taking the study drugs for up to 8 cycles. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the long-term follow-up.
Long-term Follow-up:
Every 3 months for 1 year after your last study drug dose, the study staff will call you and ask how you are feeling, about any side effects you may be having, and about any other drugs you may be taking. These calls should last about 5 minutes each.
This is an investigational study. Decitabine is FDA approved and commercially available to treat myelodysplastic syndrome (MDS). Clofarabine is FDA approved and commercially available to treat ALL in children. Idarubicin and cytarabine are FDA approved and commercially available to treat AML. The study drug combination is investigational.
Up to 92 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Starting with Dose level 1, the participants were enrolled by cohort of 3. Once the DLT assessment is completed, another cohort of 3 patients will be enrolled. If at any time, we see more than 30% patients experiencing DLT, we will de-escalate to dose level (-1). Period 1: Dose level 1 Clofarabine 15mg/m^2 daily x 4 days (days 6-9) Period 2: Dose level-1 Clofarabine 15mg/m^2 daily x 3 days (days 6-8)
| Arm | Type | Receives |
|---|---|---|
| Clofarabine + Cytarabine + Decitabine + Idarubicin | Experimental | Drug: Decitabine, Drug: Idarubicin, Drug: Cytarabine, Drug: ClofarabinePhase I - Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10) Phase II - Clofarabine 15 mg/m2 by vein over approximately 1 hour daily (number of days selected based on Phase I portion). Decitabine 20 mg/m2 by vein over approximately 1 hour daily for 5 days (days 1-5) Idarubicin 10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 6-8) Cytarabine 1 g/m2 by vein over approximately 2 hours daily for 5 days (days 6-10) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Sign an IRB-approved informed consent document.
- Age >/= 18 years and <65 years.
- Diagnosis of AML [other than acute promyelocytic leukemia] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed
- ECOG performance status of </=2 at study entry.
- Organ function as defined below (unless due to leukemia):Serum creatinine </= 3 mg/dL;Total bilirubin </= 2.5 mg/dL; ALT (SGPT) </= 3 x ULN or </= 5 x ULN if related to disease
Key exclusion criteria (4 listed)
- Breast feeding women
- Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
- Patients with active secondary malignancy will not be eligible unless approved by the PI.
- NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study
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 |
|---|---|---|
| DecitabineAlso: DacogenPhase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5) | Drug | Clofarabine + Cytarabine + Decitabine + Idarubicin |
| IdarubicinAlso: IdamycinPhase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8) | Drug | Clofarabine + Cytarabine + Decitabine + Idarubicin |
| CytarabineAlso: Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine HydrochloridePhase I and II - 1 g/m2 by vein daily for 5 days (days 6-10) | Drug | Clofarabine + Cytarabine + Decitabine + Idarubicin |
| ClofarabineAlso: Clofarex, ClolarPhase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9) Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion). | Drug | Clofarabine + Cytarabine + Decitabine + Idarubicin |
Primary outcome
Maximum Tolerated Dose (MTD) of Clofarabine
Time frame: After second, 33 day cycle
Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).
Number of Participants With a Response
Time frame: 56 days
Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.
2 secondary outcomes
To Determine the Disease-free Survival (DFS).
Time frame: Up to 2 years after participants off study date
Overall Survival
Time frame: Up to 2 years after participants off study date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- 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.
Nitin Jain, MBBS 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 1/2 study testing Decitabine, Idarubicin and Cytarabine in people with 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 7 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 30 May 2019. 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 combined 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.
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 10 May 2019). 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?
Maximum Tolerated Dose (MTD) of Clofarabine (time frame: After second, 33 day cycle). The study lists 2 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 30 May 2019.