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

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Brief Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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


Condition

Adult Acute Megakaryoblastic Leukemia (M7)

Intervention

standard follow-up care

Study Arms / Comparison Groups

 Health services research (early discharge, outpatient care)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

December 2010

Completion Date

July 2014

Primary Completion Date

July 2014

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Roland Walter, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01235572

Organization ID

2449.00

Secondary IDs

NCI-2012-03028

Responsible Party

Sponsor

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Roland Walter, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Verification Date

February 2015