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Acute Myeloid LeukemiaPhase 3AMLNCT04571645

Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia

A Phase 3 study testing Dociparstat in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated acute myeloid leukemia (AML) with adverse or intermediate genetic risk. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Dociparstat
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
14 sitesUnited States
Study dates
30 Apr 2021to 16 May 2022
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A potential participant must have met all the following criteria to be eligible to participate in the study:
  • Had newly-diagnosed, previously untreated acute myeloid leukemia (AML) (according to the World Health Organization criteria) with at least 20% blasts in the peripheral blood or bone marrow.
  • Was aged ≥18 years.
  • Adverse genetic risk (according to European LeukemiaNet [ELN] criteria), defined as nay of the following genetic abnormalities:
  • t(6;9)(p23;q34.1); DEK-NUP214
  • - t(v;11q23.3); KMT2A rearranged
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  • - t(9;22)(q34.1;q11.2); BCR-ABL1
  • - inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2, MECOM(EVI1)
  • - -5 or del(5q); -7; -17/abn(17p)
  • - Complex karyotype, monosomal karyotype
  • - Wild-type NPM1 and FLT3-ITDhigh
  • - Mutated RUNX1, mutated ASXL1, or mutated TP53 OR
  • Intermediate genetic risk (according to ELN criteria), defined as any of the following genetic abnormalities:
  • Mutated NPM1 and FLT3-ITDhigh
  • - Wild-type NPM1 without FLT3-ITD or with FLT3-ITDlow (without adverse-risk genetic lesions)
  • - t(9;11)(p21.3;q23.3); MLLT3-KMT2A
  • - Cytogenetic abnormalities not classified as favorable or adverse
  • Had an Eastern Cooperative Oncology Group performance status of 0 to 2.
  • Provided written informed consent to participate in the study.

Who cannot join

  • A potential participant who met any of the follow criteria was not eligible to participate in the study:
  • Leukemia exclusions:
  • Had acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia.
  • Not applicable (criterion removed in Amendment 1 of the Clinical Study Protocol).
  • Not applicable (criterion removed in Amendment 1 of the Clinical Study Protocol).
  • Had clinical evidence of central nervous system leukemia.
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  • Prior/Concomitant Therapy:
  • Had previously received AML treatment, including Vyxeos (CPX-351, liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin, or any other prohibited concomitant AML therapy previously received or anticipated to start during the study.
  • Note: Prior hydroxyurea and emergency leukapheresis to control white blood cell count were allowed. All-trans retinoic acid during workup and a single dose of intrathecal cytarabine and/or methotrexate was permitted for participants who were undergoing lumbar puncture to evaluate central nervous system involvement.
  • Were receiving any form of anticoagulant therapy (e.g., unfractionated heparin, low molecular weight heparin, coumadin, factor Xa inhibitors).
  • Note: Heparin flush of indwelling catheters was permitted.
  • Received treatment with any other investigational agent within 28 days or 5 half-lives, whichever was longer, prior to baseline.
  • Underwent any major surgery or radiation therapy within 28 days prior to baseline.
  • Medical conditions:
  • Had immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
  • Had active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; a history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant (in the judgement of the Investigator) gastrointestinal bleeding within 3 weeks prior to randomization.
  • Had the presence of significant active or uncontrolled infection, including human immunodeficiency virus (HIV) or hepatitis B or C.
  • Note: Subjects with an infection who were receiving treatment (antibiotic, antifungal, or antiviral treatment) may have entered into the study but must have been afebrile and hemodynamically stable for ≥72 hours. Patients who had current evidence of invasive fungal infection (positive blood or tissue culture) must have had subsequent negative cultures to be eligible.
  • Had active (uncontrolled, metastatic) second malignancy. Note: A second malignancy that was in remission was permitted if there was clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy that was documented by imaging, tumor marker studies, etc. Long-term nonchemotherapy treatment (e.g., hormonal therapy) was acceptable.
  • Had psychiatric or neurological conditions that could have compromised participant safety or compliance.
  • Had a history of severe congestive heart failure or other cardiac disease that contraindicated the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%, as determined by echocardiography or multigated acquisition scan).
  • Diagnostic assessments:
  • Had a corrected QT interval >480 msec.
  • Had severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate <30 mL/min/1.73 m2.
  • Had alanine aminotransferase or aspartate aminotransferase >3x the upper limit of normal (ULN) or total bilirubin >2x the ULN.
  • Other:
  • Was a woman of childbearing potential who was pregnant, breastfeeding, and/or not using a highly effective method of contraception (consistent with local regulations regarding the methods of contraception for those participating in clinical studies).
  • Had a history of allergy or hypersensitivity to heparin, pork, or any excipients in the dociparstat formulation.
  • Had any other condition, including abnormal laboratory values that, in the judgement of the Investigator, could have put the participant at increased risk or interfered with the conduct or planned analyses of the study.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903

  • Baylor

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • East Carolina University Vidant Medical Center

    Greenville, North Carolina, 27834

  • New York Medical College

    Hawthorne, New York, 10595

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207

  • Allina Health System / Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Mount Sanai School of Medicine

    New York, New York, 10029

  • UC Irvine Medical Center

    Orange, California, 92868

  • University of Utah / Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Spartanburg Medical Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated acute myeloid leukemia (AML) with adverse or intermediate genetic risk.

Read the detailed description

A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of dociparstat sodium in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly-diagnosed acute myeloid leukemia (AML) patients.

Being tested
Dociparstat, Control
Keywords
AML
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.

  • DociparstatDrug

    Also called DSTAT, CX-01, 2-0,3-0 desulfated heparin, ODSH

    Dociparstat is a glycosaminoglycan derived from porcine heparin.

  • ControlOther

    Also called 0.9% Normal Saline, Normal saline, Sodium chloride 0.9%

    0.9% Normal Saline

Study groups in NCT04571645
Study groupRoleWhat they receive
DociparstatExperimentalTreatment with standard intensive induction, reinduction, or consolidation chemotherapy and dociparstat 4 mg/kg intravenous (IV) bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Receives: Drug: Dociparstat
ControlPlacebo comparatorTreatment with standard intensive induction, reinduction, or consolidation chemotherapy and placebo intravenous (IV) bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival was defined for all study participants through 5 years after randomization.

    Overall survival was to be measured from the date of randomization to the date of death from any cause. Participants not known to have died at last follow-up contact were to be censored on the date they were last known to be alive.

    Due to early termination, subjects did not complete long term follow-up and efficacy (including overall survival outcome) was not analyzed.

    Measured: Measured from randomization to date of death from any cause, up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2020
  2. Study start30 Apr 2021
  3. Primary completion16 May 2022
  4. Study completion16 May 2022

Why it stopped: Study enrollment was terminated on 16 May 2022 due to slow recruitment.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571645
Sponsor's protocol ID
CMX-DS-003
Acronym
AML
Status last verified
Mar 2024
First submitted
25 Sep 2020
Last updated
15 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dociparstat in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 14 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 19 inclusion and 29 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: stopped early, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Apr 2024). 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?

Overall Survival (time frame: Measured from randomization to date of death from any cause, up to 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04571645.

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 15 Apr 2024.

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