Clinical Trial Detail

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Clinical Trial Detail

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

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 (Adult, Senior)

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

- 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

-- * 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 / 206-606-1024

Keywords: Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Myelodysplastic Syndromes (MDS); Leukemia, Myeloid; Neoplasms; Preleukemia; Bone Marrow Diseases

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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