Acute Myelogenous LeukemiaPhase 2NCT03820908
Bisantrene for Relapsed /Refractory AML
A Phase 2 study testing Bisantrene in people with Acute Myelogenous Leukemia and Allogeneic Stem Cell Transplantation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Allogeneic Stem Cell Transplantation
- What is being tested?
- Bisantrene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Jul 2019to 22 Jul 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
- Disease-related:
- Patients with Rel/Ref/AML
- Adequate birth control in fertile patients.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Demographic:
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- Age ≥ 18 years and willing and able to comply with the protocol requirements
- Life expectancy ≥ 3 months Ethical/Other
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.
- Male subjects must agree to practice contraception
Who cannot join
- Disease-related
- Patients with other type of basic disease other than Rel/Ref AML.
- Patients with respiratory failure (DLCO < 30%).
- Patients with active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
- Patients with > grade II liver renal toxicity.
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
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- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- Creatinine > 2.0 mg/dl
- ECOG-Performance status > 2
- CNS disease involvement
- Severe pleural effusion and ascites. Concurrent Conditions
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- Pregnant or lactating females
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection
- Non hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Patients with relapse or disease progression >3 months post HSCT are allowed into the study unless they have severe (grade III-IV) GVHD.
- Patients with grade III-IV GVHD will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)
Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .
- Being tested
- Bisantrene
- Keywords
- relapsed AML, refractory 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.
BisantreneDrug
The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.
| Study group | Role | What they receive |
|---|---|---|
| Bisantrene | Experimental | patients will receive bisantrene 250mg/m2/d for 7 days Receives: Drug: Bisantrene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
Measured: 24 months
Leukemia-free survival
Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start18 Jul 2019
- Primary completion19 May 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The patientswith Rel /Ref AML will receive bisantrene in conjunction with the conventional supportive care. In the event of a CR, patients will receive a 3-day consolidation course of bisantrene 250mg/m2/d (optional).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Racura Oncology Ltd
- Responsible party
- Principal investigator, Prof Arnon Nagler, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820908
- Sponsor's protocol ID
- 5792-18 - SMC
- Status last verified
- Aug 2020
- First submitted
- 24 Jan 2019
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT03820908
- Acronym / sponsor ID
- 5792-18 - SMC
- Keywords
- relapsed AML, refractory AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Racura Oncology Ltd
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- 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.
Induction of response in patients with AML that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patientswith Rel /Ref AML will receive bisantrene in conjunction with the conventional supportive care. In the event of a CR, patients will receive a 3-day consolidation course of bisantrene 250mg/m2/d (optional).
| Arm | Type | Receives |
|---|---|---|
| Bisantrene | Experimental | Drug: Bisantrenepatients will receive bisantrene 250mg/m2/d for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.
- Patients with Rel/Ref/AML
- Adequate birth control in fertile patients.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age ≥ 18 years and willing and able to comply with the protocol requirements
Key exclusion criteria (20 listed)
- Disease-related
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- Patients with grade III-IV GVHD will be excluded from the study.
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 |
|---|---|---|
| BisantreneThe patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care. | Drug | Bisantrene |
Primary outcome
Overall survival
Time frame: 24 months
Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
Leukemia-free survival
Time frame: 24 months
Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
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 7 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bisantrene in people with Acute Myelogenous Leukemia and Allogeneic Stem Cell Transplantation, run by Sheba Medical Center at 1 site in Israel.
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 11 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 7 Aug 2020. 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 Israel. 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?
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?
Overall survival (time frame: 24 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 7 Aug 2020.