A Phase 1 interventional study of Dociparstat sodium in Acute Myeloid Leukemia, sponsored by Chimerix. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Chimerix · Phase 1, Interventional, and Treatment
This was an open-label pilot study that evaluated the safety and preliminary evidence of a therapeutic effect of dociparstat in conjunction with standard induction and consolidation therapy for acute myeloid leukemia (AML).
The primary objectives of this study were the following:
The secondary objectives of this study were the following:
This study enrolled patients with newly diagnosed, previously untreated AML; subjects with acute promyelocytic leukemia and acute megakaryoblastic leukemia subtypes were excluded.
All patients were to receive standard induction chemotherapy with cytarabine 100 mg/m2/day by continuous intravenous (IV) infusion over 24 hours daily for 7 days (Days 1-7) plus idarubicin 12 mg/m2/day by IV injection daily for 3 days (Days 1-3). For consolidation, patients younger than 60 were to receive cytarabine at a dose of 3 grams/m2 over 3 hours, every 12 hours on days 1, 3, and 5.
Induction cycle: dociparstat 4 mg/kg IV bolus Day 1, 30 minutes after completion of administration of the first dose of idarubicin, then dociparstat 0.25 mg/kg/hour for 24 hours daily by continuous IV infusion Days 1-7.
Consolidation cycle: dociparstat mg/kg IV bolus Day 1 administered 30 minutes after completion of infusion of the first dose of cytarabine then dociparstat 0.25 mg/kg/hour for 24 hours daily by continuous IV infusion Days 1-5
In total, there were 7 days in the induction cycle and 5 days in the consolidation cycles.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Chimerix is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients had to meet the following criteria to be eligible for this study:
Exclusion Criteria:
Patients who met any of the following criteria were not eligible to be enrolled in this study:
The following induction regimen was administered: * 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.
Drug: Dociparstat sodium
The following induction regimen was administered: * 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.
Also known as: dociparstat, ODSH, CX-01, 2-O, 3-O desulfated heparin
Time (Days) to Transfusion-independent Platelet Recovery (Platelet Counts Values ≥ 20,000/μL and ≥ 50,000/μL Without a Platelet Transfusion)
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.
Time frame: Day 1 to Day 35 (35 days)
Number of Subjects Who Achieved a Morphologic Complete Remission
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.
Time frame: Day 1 to Day 35 (35 days)
| Milestone | Dociparstat |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
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.
| days | Dociparstat |
|---|---|
| Platelet count of ≥20,000/µL | 21.3 (18 to 22) |
| Platelet count of ≥50,000/µL | 23.1 (19 to 25) |
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.
| Participants | Dociparstat |
|---|---|
| Number of Subjects Who Achieved a Morphologic Complete Remission | 11 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dociparstat | — | 5/12 (41.7%) | 0/12 (0%) |
| Event | Dociparstat |
|---|---|
| SepsisInfections and infestations | 2/12 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/12 |
| Perirectal abscessInfections and infestations | 1/12 |
| Acute tubular necrosisRenal and urinary disorders | 1/12 |
| angioedemaImmune system disorders | 1/12 |
| Age, Continuous(years) | Dociparstat |
|---|---|
| Median | 54 (21 to 74) |
| Sex: Female, Male(Participants) | Dociparstat |
|---|---|
| Female | 3 |
| Male | 9 |
| Region of Enrollment(participants) | Dociparstat |
|---|---|
| United States | 12 |
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chimerix