Trial Outcomes & Findings for Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients (NCT NCT01929408)
NCT ID: NCT01929408
Last Updated: 2019-11-15
Results Overview
Percentage analyzed participants receiving HCT
Recruitment status
COMPLETED
Target enrollment
703 participants
Primary outcome timeframe
1 year after starting induction
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
Acute Myeloid Leukemia (AML) & Myelodysplastic Syndrome (MDS)
All patients starting induction therapy for newly diagnosed AML or advanced MDS and followed over time
|
|---|---|
|
Overall Study
STARTED
|
703
|
|
Overall Study
COMPLETED
|
695
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Acute Myeloid Leukemia (AML) & Myelodysplastic Syndrome (MDS)
All patients starting induction therapy for newly diagnosed AML or advanced MDS and followed over time
|
|---|---|
|
Overall Study
received HCT as initial treatment
|
8
|
Baseline Characteristics
Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
Baseline characteristics by cohort
| Measure |
All Patients
n=703 Participants
All patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
436 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
267 Participants
n=99 Participants
|
|
Age, Continuous
|
62 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
399 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
662 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
608 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
703 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 year after starting inductionPercentage analyzed participants receiving HCT
Outcome measures
| Measure |
All Patients
n=695 Participants
All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
|
|---|---|
|
Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
|
44.7 % participants
|
SECONDARY outcome
Timeframe: 1 year after starting inductionPercentage analyzed participants without HCT and Deceased
Outcome measures
| Measure |
All Patients
n=695 Participants
All eligible patients enrolled on the study for treatment of their Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) disease.
|
|---|---|
|
Percentage Analyzed Participants Without HCT and Deceased
|
32.7 % participants
|
Adverse Events
All Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 309 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mohamed Sorror, MD, MSc
Fred Hutchinson Cancer Research Center
Phone: (206) 667-6298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place