Acute Myeloid LeukemiaEarly Phase 1NCT01843634
Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
A Early Phase 1 study testing ODSH in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 1 site in United States.
Trial summary
This is an open-label pilot study evaluating the safety and preliminary evidence of a therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard induction and consolidation therapy for acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- ODSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia is excluded.
- No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed.
- No prior chemotherapy or lenalinomide for treatment of myelodysplastic syndrome.
- Age: 18-70.
- ECOG Performance status 0-2
- Cardiac ejection fraction ≥ 50% (echocardiography or MUGA [multigated acquisition])
- Adequate hepatic and renal function (AST [aminotransferase], ALT [alanine aminotransferase], bilirubin and creatinine < 2.5 x upper normal limit).
- Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Patients with acute promyelocytic leukemia
- Patients with acute megakaryoblastic leukemia
- Patients with CNS (central nervous system) leukemia
- Presence of significant active infection or uncontrolled bleeding
- Any coexisting major illness or organ failure which contraindicates the dose-intensive chemotherapy regimen prescribed by this protocol
- Pre-existing liver disease that might impair ODSH clearance
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- History of other active malignant disease within 5 years, other than cured basal cell carcinoma of the skin, cured in situ carcinoma of the cervix, or localized prostate cancer that has received definitive therapy. Such prostate cancer patients who are receiving hormonal therapy are eligible
- Use of recreational drugs or history of drug addiction, within the prior 6 months
- Known history of positive hepatitis B surface antigens or hepatitis C antibodies
- Known history of positive test for HIV (Human immunodeficiency virus) antibodies
- Psychiatric or neurologic conditions that could impair ability to give proper informed consent
- Presence of symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia
- Presence of uncontrolled thrombotic or hemorrhagic disorder
- A medical condition that requires the need to be on chronic anticoagulation
- Presence of any other serious uncontrolled medical disorder
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry
- Pregnant or breast-feeding patients
- Patient with childbearing potential not using adequate contraception
- Hemorrhage risk that requires maintenance of platelet counts at 50,000/uL or higher.
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Pilot Study to Evaluate the Safety and Preliminary Evidence of a Therapeutic Effect of ODSH (2-0, 3-0, Desulfated Heparin) in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
This is an open-label pilot study evaluating the safety and preliminary evidence of a therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard induction and consolidation therapy for acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- ODSH
- 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.
ODSHDrug
| Study group | Role | What they receive |
|---|---|---|
| ODSH | Experimental | Not described Receives: Drug: ODSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety by incidence of serious events
Measured: 12 months
Efficacy by time to platelet recovery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul J Shami, M.D., Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843634
- Sponsor's protocol ID
- IRB 63137
- Status last verified
- Aug 2015
- First submitted
- 26 Apr 2013
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Preliminary Evidence of a Therapeutic Effect of ODSH (2-0, 3-0, Desulfated Heparin) in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01843634
- Acronym / sponsor ID
- IRB 63137
- Conditions
- Acute Myeloid Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label pilot study evaluating the safety and preliminary evidence of a therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard induction and consolidation therapy for acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODSH | Experimental | Drug: ODSH |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia is excluded.
- No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed.
- No prior chemotherapy or lenalinomide for treatment of myelodysplastic syndrome.
- Age: 18-70.
- ECOG Performance status 0-2
Key exclusion criteria (20 listed)
- Patients with acute promyelocytic leukemia
- Patients with acute megakaryoblastic leukemia
- Patients with CNS (central nervous system) leukemia
- Presence of significant active infection or uncontrolled bleeding
- Any coexisting major illness or organ failure which contraindicates the dose-intensive chemotherapy regimen prescribed by this protocol
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 |
|---|---|---|
| ODSH | Drug | ODSH |
Primary outcome
Safety by incidence of serious events
Time frame: 12 months
Efficacy by time to platelet recovery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
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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.
Paul J Shami, M.D. principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ODSH in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 1 site 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 8 inclusion and 20 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety by incidence of serious events (time frame: 12 months). The study lists 2 primary outcomes in all. 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 10 Nov 2021.