Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 20 May 2013
• Main ID: NCT01235572
• Date of registration: 04/11/2010
• Primary sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
• Public title: Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
• Scientific title: Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML
• Date of first enrolment: December 2010
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01235572
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Countries of recruitment

United States

Contacts

• Name: Roland B. Walter

• Name: Roland Walter
• Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Other: medical chart review

Procedure: quality-of-life assessment

Procedure: standard follow-up care

Primary Outcome(s)

Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy [Time Frame: Up to day 35]

Secondary ID(s)

2449.00

NCI-2012-03028

P30CA015704

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)