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

Complete title: Feasibility of Outpatient Induction Chemotherapy for Adult Patients with Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Research Study Number       7910
    
Principal Investigator       Pamela Becker, MD, PhD
    
Phase       Pilot

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Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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

- White blood cell (WBC) count =< 10,000

- Fibrinogen > 200

- Afebrile with a clear chest x-ray and no signs of active viral, bacterial, or fungal infection

- 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

Other eligibility criteria may apply.



Research Study Number       7910
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia

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