Trial Outcomes & Findings for Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome (NCT NCT01807091)

NCT ID: NCT01807091

Last Updated: 2021-03-05

Results Overview

Feasibility for this study objective would be considered a "success" if \>50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: During the 4-7 days of outpatient induction chemotherapy
• Results posted on: 2021-03-05

Participant Flow

Participant milestones

Measure	Treatment (Chemotherapy) Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

Baseline characteristics by cohort

Measure	Treatment (Chemotherapy) n=17 Participants Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Treatment Related Mortality (TRM) score	1.6 units on a scale (0-100) n=5 Participants
Disease AML	15 Participants n=5 Participants
Disease MDS (EB-2)	2 Participants n=5 Participants
Disease status Newly diagnosed	8 Participants n=5 Participants
Disease status Relapsed or refractory	9 Participants n=5 Participants
Induction chemotherapy regimen Idarubicin, cytarabine, pravastatin (IAP)	2 Participants n=5 Participants
Induction chemotherapy regimen Cladribine, cytarabine, mitoxantrone, granulocyte colony-stimulating factor (GCLAM)	7 Participants n=5 Participants
Induction chemotherapy regimen Decitabine, cladribine, cytarabine, mitoxantrone, granulocyte colony-stimulating factor (D-GCLAM)	2 Participants n=5 Participants
Induction chemotherapy regimen Clofarabine, cytarabine, granulocyte colony-stimulating factor (GCLAC)	3 Participants n=5 Participants
Induction chemotherapy regimen Decitabine, mitoxantrone, etoposide, cytarabine (D-MEC)	3 Participants n=5 Participants
Number of days of predetermined treatment	5 Days of predetermined treatment n=5 Participants
Year enrolled 2010-2013	1 Participants n=5 Participants
Year enrolled 2014-2018	16 Participants n=5 Participants
Hematocrit on day 1	28 Percentage of red blood cells in blood n=5 Participants
Platelet count on day 1	71 10 x 10^9 cells/L n=5 Participants

PRIMARY outcome

Timeframe: During the 4-7 days of outpatient induction chemotherapy

Feasibility for this study objective would be considered a "success" if >50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.

Outcome measures

Measure	Treatment (Chemotherapy) n=17 Participants Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Rate of Hospital Admission During Outpatient Induction Chemotherapy Not admitted during induction chemotherapy period	14 Participants
Rate of Hospital Admission During Outpatient Induction Chemotherapy Admitted during induction chemotherapy period	3 Participants

PRIMARY outcome

Timeframe: During the 14 days after beginning outpatient induction treatment

Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.

Outcome measures

Measure

Treatment (Chemotherapy) n=17 Participants Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.

Death Within 14 Days of Initiating Outpatient Induction Chemotherapy

0 Participants

Adverse Events

Treatment (Chemotherapy)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Chemotherapy) n=17 participants at risk Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Infections and infestations Neutropenic fever	11.8% 2/17 • Number of events 2 • From the start of outpatient chemotherapy through day 14 after starting outpatient chemotherapy. Only the following adverse events were recorded: 1. Reasons for hospitalization during planned outpatient administration of chemotherapy 2. Causes of any deaths that occur within 14 days of start of outpatient chemotherapy Other adverse events were not monitored/assessed.
Gastrointestinal disorders Mucositis	5.9% 1/17 • Number of events 1 • From the start of outpatient chemotherapy through day 14 after starting outpatient chemotherapy. Only the following adverse events were recorded: 1. Reasons for hospitalization during planned outpatient administration of chemotherapy 2. Causes of any deaths that occur within 14 days of start of outpatient chemotherapy Other adverse events were not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Elihu Estey, MD

University of Washington

Phone: 206-606-6744

Email: eestey@seattlecca.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place