Clinical trial NCT01235572: Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
Official title: Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Keywords: 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
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about the safety of allowing patients to leave the hospital early, the patient's quality of life, use of medical services, and the cost of these services associated with such a policy.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy
timeFrame: Up to day 35
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Roland Walter
role: PRINCIPAL_INVESTIGATOR
References: