Acute Myeloid LeukemiaPhase 2NCT02873338
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study testing Dociparstat sodium, Idarubicin and Cytarabine in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 23 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Dociparstat sodium, Idarubicin and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 23 sitesUnited States
- Study dates
- Aug 2016to Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects had to meet all the following criteria to be eligible for enrollment in this study:
- Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
- Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Who cannot join
- Subjects who met any of the following criteria were not eligible for enrollment in this study:
- Had acute promyelocytic leukemia
- Had prior chemotherapy for AML.
- Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
- Had central nervous system (CNS) leukemia.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati
Cincinnati, Ohio, 45267
Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center
Dallas, Texas, 75246
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
Franciscan St. Francis Health
Indianapolis, Indiana, 46237
University of California, San Diego, Moores Cancer Center
La Jolla, California, 92093
Northwell Health, Monter Cancer Center
Lake Success, New York, 11042
Norton Cancer Institute
Louisville, Kentucky, 40207
Allina Health - Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Tennessee Oncology/Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Tulane University/Tulane Cancer Center
New Orleans, Louisiana, 70112
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
LDS Hospital
Salt Lake City, Utah, 84143
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229
June E. Nylen Cancer Center
Sioux City, Iowa, 51101
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
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.
Read the 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
- Being tested
- Dociparstat sodium, Idarubicin, Cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dociparstat sodiumDrug
Also called 2-O, 3-O desulfated heparin, ODSH, PGX-100, CX-01
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
Also called Idamycin
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.
| Study group | Role | What they receive |
|---|---|---|
| Control (idarubicin+cytarabine) | Active comparator | 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) Receives: Drug: Idarubicin; Drug: Cytarabine |
| Dociparstat 0.125 mg/kg | Experimental | 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) Receives: Drug: Dociparstat sodium; Drug: Idarubicin; Drug: Cytarabine |
| Dociparstat 0.25 mg/kg | Experimental | 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) Receives: Drug: Dociparstat sodium; Drug: Idarubicin; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
Secondary outcomes (10)
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.
Measured: Randomization up to 30 months
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.
Measured: Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months
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.
Measured: Randomization to end of study (18 months)
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.
Measured: Up to 60 days after the start of each treatment cycle
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)
Measured: Randomization to end of study (18 months)
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.
Measured: Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle
Time to Platelet Recovery
Platelet recovery was measured from randomization to platelet recovery (platelet count >20,000/µL and >100,000/µL)
Measured: Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle
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.
Measured: 30 days (from first day of induction treatment to 30 days after)
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.
Measured: 60 days (from the first day of induction treatment to 60 days after)
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.
Measured: 90 days (from the first day of induction treatment to 90 days after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Marcus, MD, Study director, Cantex Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873338
- Sponsor's protocol ID
- CNTX-CX-01-2015-AML-1
- Status last verified
- Aug 2023
- First submitted
- 12 Aug 2016
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02873338
- Acronym / sponsor ID
- CNTX-CX-01-2015-AML-1
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (idarubicin+cytarabine) | Active comparator | Drug: Idarubicin, Drug: CytarabineInduction: * 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) |
| Dociparstat 0.125 mg/kg | Experimental | Drug: Dociparstat sodium, Drug: Idarubicin, Drug: CytarabineInduction: * 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) |
| Dociparstat 0.25 mg/kg | Experimental | Drug: Dociparstat sodium, Drug: Idarubicin, Drug: CytarabineInduction: * 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects had to meet all the following criteria to be eligible for enrollment in this study:
- Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
- Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Key exclusion criteria (5 listed)
- Subjects who met any of the following criteria were not eligible for enrollment in this study:
- Had acute promyelocytic leukemia
- Had prior chemotherapy for AML.
- Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
- Had central nervous system (CNS) leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dociparstat sodiumAlso: 2-O, 3-O desulfated heparin, ODSH, PGX-100, CX-01Subjects 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. | Drug | Dociparstat 0.125 mg/kg, Dociparstat 0.25 mg/kg |
| IdarubicinAlso: IdamycinSubjects 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. | Drug | Control (idarubicin+cytarabine), Dociparstat 0.125 mg/kg, Dociparstat 0.25 mg/kg |
| CytarabineSubjects 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. | Drug | Control (idarubicin+cytarabine), Dociparstat 0.125 mg/kg, Dociparstat 0.25 mg/kg |
Primary outcome
Number of Subjects Who Achieved Morphologic Complete Remission
Time frame: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
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.
10 secondary outcomes
Duration of Event-free Survival
Time frame: Randomization up to 30 months
Time to Leukemia-free Survival
Time frame: Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months
Number of Subjects Who Achieved Overall Survival
Time frame: Randomization to end of study (18 months)
Number of Subjects Who Achieved Composite Complete Remission
Time frame: Up to 60 days after the start of each treatment cycle
Duration of Morphologic Complete Remission
Time frame: Randomization to end of study (18 months)
Time to Recovery of Neutrophils
Time frame: Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle
Time to Platelet Recovery
Time frame: Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle
Number of Subjects Who Died by Day 30
Time frame: 30 days (from first day of induction treatment to 30 days after)
Number of Subjects Who Died by Day 60.
Time frame: 60 days (from the first day of induction treatment to 60 days after)
Number of Subjects Who Died by Day 90
Time frame: 90 days (from the first day of induction treatment to 90 days after)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Marcus, MD study director
Cantex Pharmaceuticals Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dociparstat sodium, Idarubicin and Cytarabine in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Achieved Morphologic Complete Remission (time frame: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023; AzTrials last refreshed its copy on 3 Nov 2026.