Adult Acute Myeloid LeukemiaNCT01807091
Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
A study testing Chemotherapy in people with Adult Acute Myeloid Leukemia and Adult Myelodysplastic Syndrome, run by University of Washington at 9 sites in United States.
Trial summary
This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Acute Myeloid Leukemia, Adult Myelodysplastic Syndrome
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 May 2013to 8 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- The signed informed consent
- The benefits/risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol
- AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
- Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients
- Blast count =< 10,000
Show all 16Show fewer
- Fibrinogen > 200
- Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal infection unless determined to be, at the discretion of the investigator, not clinically significant in the context of this study
- Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram; no ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure
- Patient must have an outpatient caregiver available
- Patient must live within 30 minutes of the treating physician's office during outpatient treatment
- Patient must be willing to return to the treating physician's office for outpatient follow-up once outpatient treatment is completed
- Logistical requirements:
- Space available in infusion room
- Outpatient infusion pump available if continuous infusion required
- Case discussed with infusion room nursing staff
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
EvergreenHealth Medical Center
Kirkland, Washington, 98033
Skagit Valley Hospital
Mount Vernon, Washington, 98274
Olympic Medical Center
Port Angeles, Washington, 98362
Group Health Cooperative
Redmond, Washington, 98052
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Multicare Health System
Tacoma, Washington, 98415
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
About this study
Official title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether:
- > 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
- < 5% of patients die within 14 days of beginning outpatient chemotherapy.
OUTLINE:
Patients receive outpatient induction chemotherapy.
STATISTICAL CONSIDERATIONS:
The study was monitored to assure that there was not an excess probability of admission to the hospital during receipt of outpatient chemotherapy or death within 14 days of initiating chemotherapy as assessed by Bayesian posterior probabilities using the "predictive probabilities" tool (MD Anderson Cancer Center Department of Statistics).
Stopping earlier would happen under 2 circumstances:
- Excess probability that patients required admission to hospital during the 4-7 days of outpatient chemotherapy (predictive probability be < 0.10, or 7 patients admitted and 3 not admitted among 10 patients enrolled versus the maximum acceptable rate of 4 patients admitted and 6 not admitted among 10 patients enrolled).
- Excess probability that patients die during the 14 days after beginning outpatient treatment (predictive probability be >0.90, for example in cases where there are 2 patient deaths within 14 days and less than 5 patients without deaths within 14 days, or in any case where there are 3 patient deaths within 14 days).
- Being tested
- Chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Receive outpatient induction chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemotherapy) | Experimental | Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hospital Admission During Outpatient Induction Chemotherapy
Feasibility for this study objective would be considered a "success" if >50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
Measured: During the 4-7 days of outpatient induction chemotherapy
Death Within 14 Days of Initiating Outpatient Induction Chemotherapy
Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.
Measured: During the 14 days after beginning outpatient induction treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study start21 May 2013
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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 Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elihu H. Estey, University of Washington
- Investigators
- Pamela Becker, Principal investigator, Fred Hutch/University of Washington Cancer ConsortiumEli Estey, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807091
- Sponsor's protocol ID
- 7910
- Other IDs
- NCI-2013-00483, 7910, P30CA015704, RG1000945
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2013
- Last updated
- 5 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01807091
- Acronym / sponsor ID
- 7910
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2013 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 5 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.
Detailed description
PRIMARY OBJECTIVES:
Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether:
- > 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
- < 5% of patients die within 14 days of beginning outpatient chemotherapy.
OUTLINE:
Patients receive outpatient induction chemotherapy.
STATISTICAL CONSIDERATIONS:
The study was monitored to assure that there was not an excess probability of admission to the hospital during receipt of outpatient chemotherapy or death within 14 days of initiating chemotherapy as assessed by Bayesian posterior probabilities using the "predictive probabilities" tool (MD Anderson Cancer Center Department of Statistics).
Stopping earlier would happen under 2 circumstances:
- Excess probability that patients required admission to hospital during the 4-7 days of outpatient chemotherapy (predictive probability be < 0.10, or 7 patients admitted and 3 not admitted among 10 patients enrolled versus the maximum acceptable rate of 4 patients admitted and 6 not admitted among 10 patients enrolled).
- Excess probability that patients die during the 14 days after beginning outpatient treatment (predictive probability be >0.90, for example in cases where there are 2 patient deaths within 14 days and less than 5 patients without deaths within 14 days, or in any case where there are 3 patient deaths within 14 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemotherapy) | Experimental | Drug: ChemotherapyParticipants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed written informed consent
- AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
- Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients
- Blast count =< 10,000
- Fibrinogen > 200
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ChemotherapyAlso: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralReceive outpatient induction chemotherapy | Drug | Treatment (chemotherapy) |
Primary outcome
Rate of Hospital Admission During Outpatient Induction Chemotherapy
Time frame: During the 4-7 days of outpatient induction chemotherapy
Feasibility for this study objective would be considered a "success" if >50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
Death Within 14 Days of Initiating Outpatient Induction Chemotherapy
Time frame: During the 14 days after beginning outpatient induction treatment
Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- 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.
Pamela Becker principal investigator
Fred Hutch/University of Washington Cancer Consortium
Eli Estey principal investigator
Fred Hutch/University of Washington Cancer Consortium
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy in people with Adult Acute Myeloid Leukemia and Adult Myelodysplastic Syndrome, run by University of Washington at 9 sites 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 16 inclusion and 0 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 5 Mar 2021). 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?
Rate of Hospital Admission During Outpatient Induction Chemotherapy (time frame: During the 4-7 days of outpatient induction chemotherapy). 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 5 Mar 2021.