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Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML


Phase 2
18 Years
75 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 in Remission, 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), Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia

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Trial Information

Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML


PRIMARY OBJECTIVES:

I. Estimate the early death rate in patients discharged after completion of intensive
induction or salvage chemotherapy.

SECONDARY OBJECTIVES:

I. Compare the costs incurred by patients discharged early after induction or salvage
chemotherapy with similar patients who are discharged only after their blood counts recover.

II. Compare resource utilization (transfusions, etc.) in patients discharged early after
induction or salvage chemotherapy with similar patients who are discharged only after blood
count recovery.

III. Compare the quality of life in patients discharged early after induction or salvage
chemotherapy with similar patients who are discharged only after their blood counts recover.

OUTLINE:

Patients are discharged within 72 hours after completion of chemotherapy and undergo
standard outpatient care by a registered nurse (RN), physician assistant (PA), or
resident/fellow at a local facility or the study center approximately 3 times per week, as
clinically indicated for up to 45 days.

After completion of study, patients are followed up for 1 month.


Inclusion Criteria:



- Diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) other
than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (promyelocytic
leukemia [PML]/retinoic acid receptor [RAR]), or variants according to the 2008 World
Health Organization (WHO) classification

- Currently undergoing AML-like intensive induction or re-induction chemotherapy, or is
planned to start such therapy within 1 week

- Provide signed written informed consent

- Patients can be repeatedly enrolled in this protocol (e.g. for induction and 1st or
subsequent salvage therapy)

Exclusion Criteria:

- Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy

Outcome Description:

A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.

Outcome Time Frame:

Up to day 35

Safety Issue:

No

Principal Investigator

Roland Walter

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

2449.00

NCT ID:

NCT01235572

Start Date:

December 2010

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 in Remission
  • 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)
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Myeloid Leukemia
  • Acute myeloid leukemia with multilineage dysplasia following myelodysplastic syndrome
  • Adult acute eosinophilic leukemia
  • Adult acute basophilic leukemia
  • De
  • novo myelodysplastic syndromes
  • Secondary 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