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A Pilot Study of Dociparstat Sodium (ODSH) in Acute Myeloid Leukemia

NCT02056782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-02-21

Study results available
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Summary

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).

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-02-28
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056782 on ClinicalTrials.gov