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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02873338
Other study ID # CNTX-CX-01-2015-AML-1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2016
Est. completion date June 2019

Study information

Verified date August 2023
Source Chimerix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
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.
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.
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.

Locations

Country Name City State
United States New Mexico Cancer Care Alliance Albuquerque New Mexico
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Cincinnati Cincinnati Ohio
United States Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center Dallas Texas
United States Colorado Blood Cancer Institute Denver Colorado
United States Karmanos Cancer Institute Detroit Michigan
United States Franciscan St. Francis Health Indianapolis Indiana
United States University of California, San Diego, Moores Cancer Center La Jolla California
United States Northwell Health, Monter Cancer Center Lake Success New York
United States Norton Cancer Institute Louisville Kentucky
United States Allina Health - Virginia Piper Cancer Institute Minneapolis Minnesota
United States Tennessee Oncology/Sarah Cannon Research Institute Nashville Tennessee
United States Tulane University/Tulane Cancer Center New Orleans Louisiana
United States Oregon Health & Science University Knight Cancer Institute Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Washington University School of Medicine in St. Louis Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Methodist Healthcare System of San Antonio San Antonio Texas
United States June E. Nylen Cancer Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States George Washington University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Chimerix

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Who Achieved Morphologic Complete Remission Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
Secondary Duration of Event-free Survival Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first. Randomization up to 30 months
Secondary Time to Leukemia-free Survival Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first. Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months
Secondary Number of Subjects Who Achieved Overall Survival Overall survival was measured from the date of randomization until death from any cause. Assessments were performed every 3 months and continued until death or 18 months after the last patient was randomized, whichever came first. Randomization to end of study (18 months)
Secondary Number of Subjects Who Achieved Composite Complete Remission The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) >1000/µL, platelet count >100,000/µL, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC <1000/µL and/or platelet count <100,000/, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. Up to 60 days after the start of each treatment cycle
Secondary Duration of Morphologic Complete Remission The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, >5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of >5% but =20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of >5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first.
Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse)
Randomization to end of study (18 months)
Secondary Time to Recovery of Neutrophils Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC >500/µL and >1000/µL) for up to 60 days after the start of each treatment cycle. Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle
Secondary Time to Platelet Recovery Platelet recovery was measured from randomization to platelet recovery (platelet count >20,000/µL and >100,000/µL) Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle
Secondary Number of Subjects Who Died by Day 30 Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction. 30 days (from first day of induction treatment to 30 days after)
Secondary Number of Subjects Who Died by Day 60. Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction. 60 days (from the first day of induction treatment to 60 days after)
Secondary Number of Subjects Who Died by Day 90 Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction. 90 days (from the first day of induction treatment to 90 days after)
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