Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Women's Studies, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/5/2014 |
| Start Date: | December 2010 |
Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML
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.
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.
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.
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.
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
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
206-667-4584
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium The Fred Hutchinson/University of Washington Cancer...
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