Acute Myeloid LeukemiaNCT02101983
Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)
A study testing Cytosine Arabinoside in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
Trial summary
High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cytosine Arabinoside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2017
- Phase
- Interventional
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
- Documented complete remission (CR) following induction chemotherapy as defined as (18):
- Bone marrow with <5% blasts; absence of blasts with Auer rods
- Absolute neutrophil count >1000/mcL
- Platelets >100,000/mcL
- Independence of red cell transfusions
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- Absence of extramedullary disease
- Age ≥ 55 years.
- Relapsed AML patients are eligible as long as they meet other inclusion and exclusion criteria.
- Good performance status of (ECOG 0-2), see appendix 15.3.
- Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase <3.0 x upper limit of normal, total bilirubin <1.5 x upper limit of normal unless there is a history of Gilbert's disease).
- All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison.
- Age ≥ 18 years
Who cannot join
- Active, uncontrolled viral, bacterial, or fungal infection.
- Documented CNS leukemia.
- If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
- History of prior autologous or allogeneic bone marrow/stem cell transplant.
- New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
- Pregnant or lactating women (women and men of childbearing age should use effective contraception).
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- Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
- Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
- Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia
High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course.
The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting.
Read the detailed description
The primary objective of this study is to:
- To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine (HiDAC) for AML consolidation administered in an outpatient setting.
The secondary objectives of this study are to:
- To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of care inpatient HiDAC consolidation.
- Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to that with the standard inpatient regimen.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cytosine Arabinoside
- Keywords
- Acute myeloid leukemia, outpatient consolidation treatment
- 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.
Cytosine ArabinosideDrug
Also called AraC, Cytosar U, Cytosine aribinoside, Arabinosylcytosine
| Study group | Role | What they receive |
|---|---|---|
| Outpatient HiDAC Consolidation | Experimental | Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Receives: Drug: Cytosine Arabinoside |
| Quality of Life Comparison Group | Active comparator | Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Receives: Drug: Cytosine Arabinoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.
Measured: 3 months
Secondary outcomes (2)
Number of Participants Who Successfully Completed the of Quality of Life Form
Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life.
Measured: 3 months
Mean Cost Savings
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionAug 2017
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 University of RochesterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Mulford, University of Rochester
- Investigators
- Deborah Mulford, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101983
- Sponsor's protocol ID
- 35606
- Status last verified
- Jun 2018
- First submitted
- 14 Oct 2013
- Last updated
- 27 Jun 2018
- 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 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02101983
- Acronym / sponsor ID
- 35606
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, outpatient consolidation treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Posted 27 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course.
The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting.
Detailed description
The primary objective of this study is to:
- To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine (HiDAC) for AML consolidation administered in an outpatient setting.
The secondary objectives of this study are to:
- To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of care inpatient HiDAC consolidation.
- Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to that with the standard inpatient regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient HiDAC Consolidation | Experimental | Drug: Cytosine ArabinosidePatients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. |
| Quality of Life Comparison Group | Active comparator | Drug: Cytosine ArabinosidePatients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
- Documented complete remission (CR) following induction chemotherapy as defined as (18):
- Bone marrow with <5% blasts; absence of blasts with Auer rods
- Absolute neutrophil count >1000/mcL
- Platelets >100,000/mcL
Key exclusion criteria (9 listed)
- Active, uncontrolled viral, bacterial, or fungal infection.
- Documented CNS leukemia.
- If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
- History of prior autologous or allogeneic bone marrow/stem cell transplant.
- New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
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 |
|---|---|---|
| Cytosine ArabinosideAlso: AraC, Cytosar U, Cytosine aribinoside, Arabinosylcytosine | Drug | Outpatient HiDAC Consolidation, Quality of Life Comparison Group |
Primary outcome
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
Time frame: 3 months
To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.
2 secondary outcomes
Number of Participants Who Successfully Completed the of Quality of Life Form
Time frame: 3 months
Mean Cost Savings
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Mulford, M.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosine Arabinoside in people with Acute Myeloid Leukemia, run by University of Rochester 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 13 inclusion and 9 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 Jun 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2018). 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 Grades 3 to 5 Non-hematologic Toxicity. (time frame: 3 months). 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 Jun 2018.