Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

NCT01807091 | Completed Results

• 4 other identifiers: 7910NCI-2013-00483P30CA015704RG1000945
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 9

Brief 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. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.

Conditions

Adult Acute Myeloid Leukemia; Adult Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During the 14 days after beginning outpatient induction treatment

Study Arms (1)

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.

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

Receive outpatient induction chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Treatment (chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

EvergreenHealth Medical Center

Kirkland, Washington, 98033, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Olympic Medical Center

Port Angeles, Washington, 98362, United States

Location

Group Health Cooperative

Redmond, Washington, 98052, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Multicare Health System

Tacoma, Washington, 98415, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Slow accrual was due to initial limitation of enrollment to younger patients receiving initial induction. It was expanded to include older patients, including those receiving salvage induction. The ability to give outpatient induction was often logistically limited. Because of these issues, only 17 patients were treated and it is likely there was significant selection bias, complicating interpretation of the results.

Results Point of Contact

• Title: Elihu Estey, MD
• Organization: University of Washington

eestey@seattlecca.org

206-606-6744

Study Officials

• Pamela Becker

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Eli Estey

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: May 21, 2013
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-02

Locations

US (9)