Trial Outcomes & Findings for A Pilot Study of Dociparstat Sodium (ODSH) in Acute Myeloid Leukemia (NCT NCT02056782)
NCT ID: NCT02056782
Last Updated: 2023-02-21
Results Overview
A primary endpoint of this study was evidence of an effect of dociparstat on transfusion independent platelet recovery time. The time (days) to transfusion-independent platelet recovery will be defined as the number of days from the first day of chemotherapy until the first of 5 consecutive days with platelet counts values ≥ 20,000/μL and ≥ 50,000/μL without a platelet transfusion.
COMPLETED
PHASE1
12 participants
Day 1 to Day 35 (35 days)
2023-02-21
Participant Flow
Participant milestones
| Measure |
Dociparstat
Subjects received the following dosing regimen:
* Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days.
* Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3.
* Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Dociparstat Sodium (ODSH) in Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Dociparstat
n=12 Participants
Subjects received the following dosing regimen:
* Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days.
* Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3.
* Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days.
|
|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 35 (35 days)Population: Count recovery was analyzed after induction on the 10 subjects who received a full induction cycle.
A primary endpoint of this study was evidence of an effect of dociparstat on transfusion independent platelet recovery time. The time (days) to transfusion-independent platelet recovery will be defined as the number of days from the first day of chemotherapy until the first of 5 consecutive days with platelet counts values ≥ 20,000/μL and ≥ 50,000/μL without a platelet transfusion.
Outcome measures
| Measure |
Dociparstat
n=10 Participants
Subjects received the following dosing regimen:
* Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days.
* Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3.
* Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days.
|
|---|---|
|
Time (Days) to Transfusion-independent Platelet Recovery (Platelet Counts Values ≥ 20,000/μL and ≥ 50,000/μL Without a Platelet Transfusion)
Platelet count of ≥20,000/µL
|
21.3 days
Interval 18.0 to 22.0
|
|
Time (Days) to Transfusion-independent Platelet Recovery (Platelet Counts Values ≥ 20,000/μL and ≥ 50,000/μL Without a Platelet Transfusion)
Platelet count of ≥50,000/µL
|
23.1 days
Interval 19.0 to 25.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 35 (35 days)Population: All randomized subjects were included in this analysis, including the 2 subjects who did not complete induction.
A secondary endpoint of this study was to determine whether there was preliminary evidence of an effect of dociparstat on remission rate following cytarabine and idarubicin induction in acute myeloid leukemia (AML) patients, which included complete remission (CR) rate (with neutrophil and platelet count recovery) after the first induction cycle. Morphologic CR was defined as absolute neutrophil count (ANC) \>1000/μL, platelet count \>100,000/μL, \<5% bone marrow blasts, no Auer rods, and no evidence of extramedullary disease.
Outcome measures
| Measure |
Dociparstat
n=12 Participants
Subjects received the following dosing regimen:
* Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days.
* Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3.
* Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days.
|
|---|---|
|
Number of Subjects Who Achieved a Morphologic Complete Remission
|
11 Participants
|
Adverse Events
Dociparstat
Serious adverse events
| Measure |
Dociparstat
n=12 participants at risk
Subjects received the following dosing regimen:
* Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days.
* Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3.
* Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days.
|
|---|---|
|
Infections and infestations
Sepsis
|
16.7%
2/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Perirectal abscess
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Acute tubular necrosis
|
8.3%
1/12 • Number of events 1
|
|
Immune system disorders
angioedema
|
8.3%
1/12 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place