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Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome


N/A
18 Years
59 Years
Open (Enrolling)
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), de Novo Myelodysplastic Syndromes, Untreated Adult Acute Myeloid Leukemia

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Trial Information

Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome


PRIMARY OBJECTIVES:

I. 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 or < 5% of patients
die within 14 days of beginning outpatient chemotherapy.

OUTLINE:

Patients receive outpatient induction chemotherapy.


Inclusion Criteria:



- 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

- Newly diagnosed AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS
(10-19% blasts in marrow or blood)

- Treatment-related mortality (TRM) score < 3.91 corresponding to a TRM rate of 1% 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 Seattle Cancer Care Alliance during
outpatient treatment

- Patient must be willing to return to the Seattle Cancer Care Alliance 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of hospital admission

Outcome Time Frame:

During the 4-7 days of outpatient chemotherapy

Safety Issue:

No

Principal Investigator

Pamela Becker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

7910

NCT ID:

NCT01807091

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • de Novo Myelodysplastic Syndromes
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Chronic

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109