Acute Myeloid Leukemia
Conditions
Brief summary
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
Interventions
DRUGCytarabine consolidation
Cytarabine-based consolidation per institutional standards.
Allogeneic stem cell transplant per institutional standards.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years 2. Able to give informed consent 3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2
Exclusion criteria
1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy 2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up 3. Pregnancy: Women of childbearing potential who are β- HCG+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse Free Survival | 2 years | Percentage of participants alive and without relapsed disease at two years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Leukemia Stem Cells - Consolidation Without LSC, standard cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. | 2 |
| Leukemia Stem Cells - Consolidation LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. | 2 |
| Leukemia Stem Cells - Transplant LSC present, randomized to allogeneic transplant
Allogeneic transplant: Allogeneic stem cell transplant per institutional standards. | 6 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible in retrospect | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | No Leukemia Stem Cells - Consolidation | Leukemia Stem Cells - Consolidation | Leukemia Stem Cells - Transplant | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 6 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 1 / 6 |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 6 |
Outcome results
Primary
Relapse Free Survival
Percentage of participants alive and without relapsed disease at two years.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Leukemia Stem Cells - Consolidation | Relapse Free Survival | 0 percentage of participants |
| Leukemia Stem Cells - Consolidation | Relapse Free Survival | 0 percentage of participants |
| Leukemia Stem Cells - Transplant | Relapse Free Survival | 0 percentage of participants |