Adult Acute Myeloid Leukemia, Adult Myelodysplastic Syndrome
Conditions
Brief summary
This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.
Detailed description
PRIMARY OBJECTIVES: Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether: 1. \> 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital. 2. \< 5% of patients die within 14 days of beginning outpatient chemotherapy. OUTLINE: Patients receive outpatient induction chemotherapy. STATISTICAL CONSIDERATIONS: The study was monitored to assure that there was not an excess probability of admission to the hospital during receipt of outpatient chemotherapy or death within 14 days of initiating chemotherapy as assessed by Bayesian posterior probabilities using the predictive probabilities tool (MD Anderson Cancer Center Department of Statistics). Stopping earlier would happen under 2 circumstances: 1. Excess probability that patients required admission to hospital during the 4-7 days of outpatient chemotherapy (predictive probability be \< 0.10, or 7 patients admitted and 3 not admitted among 10 patients enrolled versus the maximum acceptable rate of 4 patients admitted and 6 not admitted among 10 patients enrolled). 2. Excess probability that patients die during the 14 days after beginning outpatient treatment (predictive probability be \>0.90, for example in cases where there are 2 patient deaths within 14 days and less than 5 patients without deaths within 14 days, or in any case where there are 3 patient deaths within 14 days).
Interventions
DRUGChemotherapy
Receive outpatient induction chemotherapy
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent * The signed informed consent * The benefits/risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol * AML (acute promyelocytic leukemia \[APL\] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood) * Treatment-related mortality (TRM) score \< 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients * Blast count =\< 10,000 * Fibrinogen \> 200 * Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal infection unless determined to be, at the discretion of the investigator, not clinically significant in the context of this study * Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram; no ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure * Patient must have an outpatient caregiver available * Patient must live within 30 minutes of the treating physician's office during outpatient treatment * Patient must be willing to return to the treating physician's office for outpatient follow-up once outpatient treatment is completed * Logistical requirements: * Space available in infusion room * Outpatient infusion pump available if continuous infusion required * Case discussed with infusion room nursing staff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hospital Admission During Outpatient Induction Chemotherapy | 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. |
| Death Within 14 Days of Initiating Outpatient Induction Chemotherapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Treatment (Chemotherapy) |
|---|---|
| Age, Continuous | 53 years |
| Disease AML | 15 Participants |
| Disease MDS (EB-2) | 2 Participants |
| Disease status Newly diagnosed | 8 Participants |
| Disease status Relapsed or refractory | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Hematocrit on day 1 | 28 Percentage of red blood cells in blood |
| Induction chemotherapy regimen Cladribine, cytarabine, mitoxantrone, granulocyte colony-stimulating factor (GCLAM) | 7 Participants |
| Induction chemotherapy regimen Clofarabine, cytarabine, granulocyte colony-stimulating factor (GCLAC) | 3 Participants |
| Induction chemotherapy regimen Decitabine, cladribine, cytarabine, mitoxantrone, granulocyte colony-stimulating factor (D-GCLAM) | 2 Participants |
| Induction chemotherapy regimen Decitabine, mitoxantrone, etoposide, cytarabine (D-MEC) | 3 Participants |
| Induction chemotherapy regimen Idarubicin, cytarabine, pravastatin (IAP) | 2 Participants |
| Number of days of predetermined treatment | 5 Days of predetermined treatment |
| Platelet count on day 1 | 71 10 x 10^9 cells/L |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
| Treatment Related Mortality (TRM) score | 1.6 units on a scale (0-100) |
| Year enrolled 2010-2013 | 1 Participants |
| Year enrolled 2014-2018 | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 3 / 17 |
Outcome results
Primary
Death Within 14 Days of Initiating Outpatient Induction Chemotherapy
Feasibility for this study objective would be considered a success if \<5% of patients die within 14 days of beginning outpatient chemotherapy.
Time frame: During the 14 days after beginning outpatient induction treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (Chemotherapy) | Death Within 14 Days of Initiating Outpatient Induction Chemotherapy | 0 Participants |
Primary
Rate of Hospital Admission During 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.
Time frame: During the 4-7 days of outpatient induction chemotherapy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Chemotherapy) | Rate of Hospital Admission During Outpatient Induction Chemotherapy | Not admitted during induction chemotherapy period | 14 Participants |
| Treatment (Chemotherapy) | Rate of Hospital Admission During Outpatient Induction Chemotherapy | Admitted during induction chemotherapy period | 3 Participants |