Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Procedure: standard follow-up care Other: medical chart review Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML |
- Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy [ Time Frame: Up to day 35 ] [ Designated as safety issue: No ]A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Health services research (early discharge, outpatient care)
Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, 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.
|
Procedure: standard follow-up care
Undergo early discharge and standard outpatient care
Other: medical chart review
Undergo early discharge and standard outpatient care
Other Name: chart review
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Roland B. Walter 206-667-3599 | |
| Principal Investigator: Roland B. Walter | |
| Principal Investigator: | Roland Walter | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01235572 History of Changes |
| Other Study ID Numbers: | 2449.00, NCI-2012-03028, P30CA015704 |
| Study First Received: | November 4, 2010 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 |
Additional relevant MeSH terms:
|
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 Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Myelodysplastic-Myeloproliferative Diseases |
ClinicalTrials.gov processed this record on May 19, 2013