NCT04571645

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dociparstat	Dociparstat is a glycosaminoglycan derived from porcine heparin.
OTHER	Control	0.9% Normal Saline

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2020-10-01
• Last updated: 2024-04-15
• Results posted: 2024-04-15

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study