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

NCT01235572 | Completed Phase 2

• 2 other identifiers: 2449.00NCI-2012-03028
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

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

  Up to day 35

Study Arms (1)

Health services research (early discharge, outpatient care)

EXPERIMENTAL

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; Other: medical chart review; Procedure: quality-of-life assessment

Interventions

standard follow-up care PROCEDURE

Undergo early discharge and standard outpatient care

Health services research (early discharge, outpatient care)

medical chart review OTHER

Undergo early discharge and standard outpatient care

Also known as: chart review

Health services research (early discharge, outpatient care)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Health services research (early discharge, outpatient care)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Basophilic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Study Officials

• Roland Walter

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 31, 2020

Record last verified: 2015-02

Locations

US (1)