Acute Myeloid Leukemia
Conditions
Brief summary
This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, 7+3) and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.
Detailed description
The primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for AML increased the complete remission rate based on the International Working Group AML response criteria. A total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups: * Group 1: cytarabine + idarubicin * Group 2: cytarabine + idarubicin + dociparstat 0.125 mg/kg/hr * Group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.
Interventions
Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy.
DRUGIdarubicin
Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy.
DRUGCytarabine
Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5.
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects had to meet all the following criteria to be eligible for enrollment in this study: 1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML). 2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion criteria
Subjects who met any of the following criteria were not eligible for enrollment in this study: 1. Had acute promyelocytic leukemia 2. Had prior chemotherapy for AML. 3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome. 4. Had central nervous system (CNS) leukemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Achieved Morphologic Complete Remission | During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle) | Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) \>1000/microliter; platelet count \>100,000, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Leukemia-free Survival | Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months | Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first. |
| Number of Subjects Who Achieved Overall Survival | Randomization to end of study (18 months) | Overall survival was measured from the date of randomization until death from any cause. Assessments were performed every 3 months and continued until death or 18 months after the last patient was randomized, whichever came first. |
| Number of Subjects Who Achieved Composite Complete Remission | Up to 60 days after the start of each treatment cycle | The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) \>1000/μL, platelet count \>100,000/μL, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC \<1000/μL and/or platelet count \<100,000/, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. |
| Duration of Morphologic Complete Remission | Randomization to end of study (18 months) | The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, \>5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of \>5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of \>5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first. Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse) |
| Duration of Event-free Survival | Randomization up to 30 months | Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first. |
| Time to Platelet Recovery | Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle | Platelet recovery was measured from randomization to platelet recovery (platelet count \>20,000/µL and \>100,000/µL) |
| Number of Subjects Who Died by Day 30 | 30 days (from first day of induction treatment to 30 days after) | Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction. |
| Number of Subjects Who Died by Day 60. | 60 days (from the first day of induction treatment to 60 days after) | Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction. |
| Number of Subjects Who Died by Day 90 | 90 days (from the first day of induction treatment to 90 days after) | Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction. |
| Time to Recovery of Neutrophils | Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle | Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC \>500/µL and \>1000/µL) for up to 60 days after the start of each treatment cycle. |
Countries
United States
Participant flow
Pre-assignment details
Note that 2 randomized subjects did not receive study treatment: 1 subject in the control group and 1 subject in the dociparstat 0.25 mg/kg group. Therefore, these 2 subjects are not included in the safety analysis, but are included in the efficacy analyses.
Participants by arm
| Arm | Count |
|---|---|
| Control (Idarubicin+Cytarabine) Induction:
* Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) | 26 |
| Dociparstat 0.125 mg/kg Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) | 25 |
| Dociparstat 0.25 mg/kg Induction:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)
Re-induction:
* Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
* Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
* Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)
Consolidation:
* Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
* Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5) | 24 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 |
| Overall Study | Death | 2 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 2 | 0 |
| Overall Study | Other or Missing | 14 | 15 | 13 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Dociparstat 0.25 mg/kg | Dociparstat 0.125 mg/kg | Control (Idarubicin+Cytarabine) |
|---|---|---|---|---|
| Acute myeloid leukemia (AML) subtype De novo | 62 Participants | 22 Participants | 18 Participants | 22 Participants |
| Acute myeloid leukemia (AML) subtype Secondary | 13 Participants | 2 Participants | 7 Participants | 4 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 4.2 | 68 years STANDARD_DEVIATION 4.3 | 67 years STANDARD_DEVIATION 4.8 | 67 years STANDARD_DEVIATION 3.6 |
| Baseline blasts in bone marrow | 46 percentage STANDARD_DEVIATION 24.6 | 46 percentage STANDARD_DEVIATION 26.6 | 47 percentage STANDARD_DEVIATION 22.3 | 44 percentage STANDARD_DEVIATION 25.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 1 Participants | 2 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 | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 20 Participants | 22 Participants | 23 Participants |
| Sex: Female, Male Female | 29 Participants | 13 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 46 Participants | 11 Participants | 15 Participants | 20 Participants |
| Time since acute myeloid leukemia (AML) diagnosis | 1.1 weeks STANDARD_DEVIATION 1.04 | 1.0 weeks STANDARD_DEVIATION 0.75 | 1.2 weeks STANDARD_DEVIATION 1.15 | 1.1 weeks STANDARD_DEVIATION 1.19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 26 | 14 / 25 | 9 / 24 |
| other Total, other adverse events | 25 / 25 | 25 / 25 | 23 / 23 |
| serious Total, serious adverse events | 7 / 25 | 8 / 25 | 13 / 23 |
Outcome results
Primary
Number of Subjects Who Achieved Morphologic Complete Remission
Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) \>1000/microliter; platelet count \>100,000, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.
Time frame: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Achieved Morphologic Complete Remission | 14 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Achieved Morphologic Complete Remission | 8 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Achieved Morphologic Complete Remission | 11 Participants |
Secondary
Duration of Event-free Survival
Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first.
Time frame: Randomization up to 30 months
Population: Note: In the Dociparstat 0.125 mg/kg group, fewer than half of the subjects achieved complete CR, and thus were assessed as having an event on Day 1.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Duration of Event-free Survival | 243.5 days |
| Dociparstat 0.125 mg/kg | Duration of Event-free Survival | 1 days |
| Dociparstat 0.25 mg/kg | Duration of Event-free Survival | 171.5 days |
Secondary
Duration of Morphologic Complete Remission
The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, \>5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of \>5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of \>5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first. Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse)
Time frame: Randomization to end of study (18 months)
Population: This analysis only included subjects who had achieved morphologic complete remission.~The following number of subjects were censored in each treatment group for this analysis; however the full ranges include censored subjects:~* Control: 7/14 (50%) subjects~* Dociparstat 0.125 mg/kg: 6/8 (75.0%) subjects~* Dociparstat 0.25 mg/kg: 9/11 (81.8%) subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Duration of Morphologic Complete Remission | 233 days |
| Dociparstat 0.125 mg/kg | Duration of Morphologic Complete Remission | 494 days |
| Dociparstat 0.25 mg/kg | Duration of Morphologic Complete Remission | 294 days |
Secondary
Number of Subjects Who Achieved Composite Complete Remission
The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) \>1000/μL, platelet count \>100,000/μL, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC \<1000/μL and/or platelet count \<100,000/, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.
Time frame: Up to 60 days after the start of each treatment cycle
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Achieved Composite Complete Remission | 16 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Achieved Composite Complete Remission | 9 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Achieved Composite Complete Remission | 15 Participants |
Secondary
Number of Subjects Who Achieved Overall Survival
Overall survival was measured from the date of randomization until death from any cause. Assessments were performed every 3 months and continued until death or 18 months after the last patient was randomized, whichever came first.
Time frame: Randomization to end of study (18 months)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Achieved Overall Survival | Subjects died | 14 Participants |
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Achieved Overall Survival | Subjects still alive | 12 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Achieved Overall Survival | Subjects died | 14 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Achieved Overall Survival | Subjects still alive | 11 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Achieved Overall Survival | Subjects died | 9 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Achieved Overall Survival | Subjects still alive | 15 Participants |
Secondary
Number of Subjects Who Died by Day 30
Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction.
Time frame: 30 days (from first day of induction treatment to 30 days after)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Died by Day 30 | 2 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Died by Day 30 | 1 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Died by Day 30 | 3 Participants |
Secondary
Number of Subjects Who Died by Day 60.
Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction.
Time frame: 60 days (from the first day of induction treatment to 60 days after)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Died by Day 60. | 2 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Died by Day 60. | 2 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Died by Day 60. | 3 Participants |
Secondary
Number of Subjects Who Died by Day 90
Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction.
Time frame: 90 days (from the first day of induction treatment to 90 days after)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Number of Subjects Who Died by Day 90 | 2 Participants |
| Dociparstat 0.125 mg/kg | Number of Subjects Who Died by Day 90 | 3 Participants |
| Dociparstat 0.25 mg/kg | Number of Subjects Who Died by Day 90 | 3 Participants |
Secondary
Time to Leukemia-free Survival
Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first.
Time frame: Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months
Population: This analysis only included subjects who achieved composite complete remission. The following number of subjects were censored in each treatment group:~* Control: 6/16 (37.5%) subjects~* Dociparstat 0.125 mg/kg: 4/9 (44.4%) subjects~* Dociparstat 0.25 mg/kg: 10/15 (66.7%) subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control (Idarubicin+Cytarabine) | Time to Leukemia-free Survival | 292 days |
| Dociparstat 0.125 mg/kg | Time to Leukemia-free Survival | 448 days |
| Dociparstat 0.25 mg/kg | Time to Leukemia-free Survival | 166 days |
Secondary
Time to Platelet Recovery
Platelet recovery was measured from randomization to platelet recovery (platelet count \>20,000/µL and \>100,000/µL)
Time frame: Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle
Population: The following number of subjects were censored in each treatment group for each analysis (platelet recovery to \>20,000µL and \>100,000µL):~* Control: 5/26 (19.2%) subjects for \>20,000µL and 7/26 (26.9%) subjects for \>100,000µL~* Dociparstat 0.125 mg/kg: 5/25 (20%) subjects for \>20,000µL and 12/25 (48.0%) subjects for \>100,000µL~* Dociparstat 0.25 mg/kg: 8/24 (33.3%) subjects for \>20,000µL and 11/24 (45.8%) subjects for \>100,000µL
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Idarubicin+Cytarabine) | Time to Platelet Recovery | Recovery to >20,000µL | 35 days |
| Control (Idarubicin+Cytarabine) | Time to Platelet Recovery | Recovery to >100,000µL | 38 days |
| Dociparstat 0.125 mg/kg | Time to Platelet Recovery | Recovery to >20,000µL | 36 days |
| Dociparstat 0.125 mg/kg | Time to Platelet Recovery | Recovery to >100,000µL | 50 days |
| Dociparstat 0.25 mg/kg | Time to Platelet Recovery | Recovery to >20,000µL | 29 days |
| Dociparstat 0.25 mg/kg | Time to Platelet Recovery | Recovery to >100,000µL | 32 days |
Secondary
Time to Recovery of Neutrophils
Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC \>500/µL and \>1000/µL) for up to 60 days after the start of each treatment cycle.
Time frame: Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle
Population: The following number of subjects were censored in each treatment group for both analyses (neutrophil recovery to \>500/µL and \>1000/µL):~* Control: 6/26 (23.1%) subjects for both analyses (\>500/µL and \>1000/µL)~* Dociparstat 0.125 mg/kg: 9/25 (36.0%) subjects for both analyses (\>500/µL and \>1000/µL)~* Dociparstat 0.25 mg/kg: 7/24 (29.2%) subjects for \>500/µL and 11/24 (45.8%) subjects for \>1000/µL
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control (Idarubicin+Cytarabine) | Time to Recovery of Neutrophils | Recovery to >500/µL | 32 days |
| Control (Idarubicin+Cytarabine) | Time to Recovery of Neutrophils | Recovery to >1000/µL | 37 days |
| Dociparstat 0.125 mg/kg | Time to Recovery of Neutrophils | Recovery to >500/µL | 43 days |
| Dociparstat 0.125 mg/kg | Time to Recovery of Neutrophils | Recovery to >1000/µL | 42 days |
| Dociparstat 0.25 mg/kg | Time to Recovery of Neutrophils | Recovery to >500/µL | 29 days |
| Dociparstat 0.25 mg/kg | Time to Recovery of Neutrophils | Recovery to >1000/µL | 35 days |