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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01235572
First received: November 4, 2010
Last updated: July 28, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235572

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Roland Walter Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01235572     History of Changes
Other Study ID Numbers: 2449.00, NCI-2012-03028, 2449.00, P30CA015704
Study First Received: November 4, 2010
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia
Leukemia, Monocytic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Erythroblastic, Acute
Syndrome
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014