Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Antineoplastic Agents

Heparin

Daunorubicin

Calcium heparin

Idarubicin

Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and dociparstat 4 mg/kg intravenous (IV) bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.

Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and placebo intravenous (IV) bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by placebo via continuous IV infusion 24 hours daily for 5 or 7 days.

Dociparstat is a glycosaminoglycan derived from porcine heparin.

Dociparstat

Control

Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated acute myeloid leukemia (AML) with adverse or intermediate genetic risk.

A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of dociparstat sodium in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly-diagnosed acute myeloid leukemia (AML) patients.

Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Overall survival was defined for all study participants through 5 years after randomization.

Overall survival was to be measured from the date of randomization to the date of death from any cause. Participants not known to have died at last follow-up contact were to be censored on the date they were last known to be alive.

Due to early termination, subjects did not complete long term follow-up and efficacy (including overall survival outcome) was not analyzed.

Chimerix

Adverse events were collected in all subjects from the time of the first dose through 42 days after the start of the last cycle with study intervention (i.e., dociparstat or placebo administered during initial induction, reinduction, or consolidation therapy).

Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.

Dociparstat sodium: Dociparstat is a glycosaminoglycan derived from porcine heparin.

Dociparstat Sodium (DSTAT)

Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.

Placebo: 0.9% Normal Saline

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Due to low subject accrual, study enrollment was prematurely terminated on 16 May 2021. Therefore, formal statistical analyses were not performed, and no conclusions can be drawn about dociparstat with regards to efficacy.

Chief Medical Officer

Due to the early termination of the study, efficacy (overall survival) was not formally analyzed.

Spots Global Cancer Trial Database for Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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