CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Dociparstat sodiumdrug
Likely dose
Dociparstat sodium 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02056782
NCT02056782Phase 1Completed
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A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2 O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

Jazz Pharmaceuticals·interventional·Posted Feb 6, 2014·Updated Feb 21, 2023

In Brief

A Phase 1 clinical trial evaluating Dociparstat sodium for Acute Myeloid Leukemia. Completed, enrolled 12 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
Countries--
CollaboratorsTranslational Drug Development

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2014
Enrollment StartDec 1, 2013
Primary CompletionFeb 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.4 years ago

Interventions

Dociparstat sodiumdrug

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.