Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

NCT ID: NCT02873338

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-06-30

Brief 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.

Detailed Description

The primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for AML increased the complete remission rate based on the International Working Group AML response criteria.

A total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups:

• Group 1: cytarabine + idarubicin
• Group 2: cytarabine + idarubicin + dociparstat 0.125 mg/kg/hr
• Group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr

Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control (idarubicin+cytarabine)

Induction:

• Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
• Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

• Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
• Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

Group Type: ACTIVE_COMPARATOR

Idarubicin

Intervention Type: DRUG

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.

Cytarabine

Intervention Type: DRUG

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.

Dociparstat 0.125 mg/kg

Induction:

• Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
• Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
• Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

• Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
• Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
• Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

• Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

Group Type: EXPERIMENTAL

Dociparstat sodium

Intervention Type: DRUG

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.

Idarubicin

Intervention Type: DRUG

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.

Cytarabine

Intervention Type: DRUG

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.

Dociparstat 0.25 mg/kg

Induction:

• Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
• Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
• Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

• Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
• Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
• Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

• Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

Group Type: EXPERIMENTAL

Dociparstat sodium

Intervention Type: DRUG

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.

Idarubicin

Intervention Type: DRUG

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.

Cytarabine

Intervention Type: DRUG

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.

Interventions

Dociparstat sodium

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.

Intervention Type: DRUG

Idarubicin

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.

Intervention Type: DRUG

Cytarabine

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.

Intervention Type: DRUG

Other Intervention Names

2-O, 3-O desulfated heparin; ODSH; PGX-100; CX-01; Dociparstat; Idamycin

Eligibility Criteria

Inclusion Criteria

Subjects had to meet all the following criteria to be eligible for enrollment in this study:

1. Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).

2. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria

Subjects who met any of the following criteria were not eligible for enrollment in this study:

1. Had acute promyelocytic leukemia

2. Had prior chemotherapy for AML.

3. Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.

4. Had central nervous system (CNS) leukemia.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Marcus, MD

Role: STUDY_DIRECTOR

Cantex Pharmaceuticals Inc.

Locations

University of California, San Diego, Moores Cancer Center

La Jolla, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

George Washington University

Washington D.C., District of Columbia, United States

Franciscan St. Francis Health

Indianapolis, Indiana, United States

June E. Nylen Cancer Center

Sioux City, Iowa, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Tulane University/Tulane Cancer Center

New Orleans, Louisiana, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Allina Health - Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, United States

Northwell Health, Monter Cancer Center

Lake Success, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health & Science University Knight Cancer Institute

Portland, Oregon, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Tennessee Oncology/Sarah Cannon Research Institute

Nashville, Tennessee, United States

Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center

Dallas, Texas, United States

Methodist Healthcare System of San Antonio

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTX-CX-01-2015-AML-1

Identifier Type: -

Identifier Source: org_study_id