At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 75 enrolled

Drug / intervention

Dociparstat sodium +2 moredrug

Likely dose

Dociparstat sodium 4 mg/kg IV bolus followed by 0.125 or 0.25 mg/kg/hr IV infusion on Days 1-7 with standard induction therapy (idarubicin 12 mg/m2 on Days 1-3, cytarabine 100 mg/m2 on Days 1-7)AI-extracted

Key inclusion· 2

✓Newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML)
✓ECOG performance status 0-2

Key exclusion· 4

✕Acute promyelocytic leukemia
✕Prior chemotherapy for AML
✕Prior intensive chemotherapy or stem cell transplantation for myelodysplastic syndrome
✕Central nervous system (CNS) leukemia

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

Search/NCT02873338

NCT02873338Phase 2Completed

Compare CT.gov

A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

Jazz Pharmaceuticals·interventional·Posted Aug 19, 2016·Updated Sep 7, 2023

In Brief

A Phase 2 clinical trial evaluating Dociparstat sodium, Idarubicin, and 1 other intervention for Acute Myeloid Leukemia. Completed, enrolled 75 participants across 23 sites.

Detailed Summary

This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Myeloid Leukemia

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

Enrollment StartAug 2016

First PostedAug 2016

Primary CompletionJun 2019

TodayJul 2026

First PostedAug 19, 2016

Enrollment StartAug 1, 2016

Primary CompletionJun 1, 2019

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 9.9 years ago

Interventions

Dociparstat sodiumdrug

Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy.

Idarubicindrug

Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy.

Cytarabinedrug

Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5.