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Myelogenous Leukemia, AcutePhase 2NCT04989335

Bisantrene Combination for Resistant AML

A Phase 2 study testing Bisantrene, Fludarabine and Clofarabine in people with Myelogenous Leukemia, Acute, run by Sheba Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An Open-label, Phase II, Two-stage, Study of Xantrene® (Bisantrene) in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) Lead-in stage: up to 12 (up to 2 cohorts in a 3+3 dose escalation design) Efficacy stage: up to 17 (Simon… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Myelogenous Leukemia, Acute
What is being tested?
Bisantrene, Fludarabine and Clofarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteIsrael
Study dates
2 Aug 2021to 1 Dec 2025
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations.
  • Age 18 -65 (inclusive) years
  • Diagnosis of AML by World Health Organization (WHO) classification (WHO, 2016) and have received at least one line of therapy prior to enrollment into this study.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.0
  • Life expectancy ≥ 3 months.
  • Adequate organ function as evidenced by serum total bilirubin ≤ 2.0 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤4 × the upper limit of normal (ULN), serum albumin >2.8 g/dL, serum creatinine ≤2 mg/dL.
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  • Cardiac ejection fraction ≥50%, assessed by 2-Dimensional echocardiogram.
  • Pulmonary function ≥50% assessed by diffusing capacity for carbon monoxide (DLCO), and any clinically significant decrease in DLCO must not be caused by infection.
  • Negative for serum markers for HIV, Hepatitis -B, -C, and HTLV-1
  • Clinically significant non-hematologic toxicity after prior chemotherapy has recovered to Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  • Females must be surgically or biologically sterile or postmenopausal (amenorrhoeic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before study entry, and must agree to use an adequate method of contraception, i.e. barrier method, during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception, i.e. barrier method, during the study until 30 days after the last treatment.

Who cannot join

  • Acute promyelocytic leukemia (APML, APL) M3 subtype of AML.
  • Other active malignancy (including other hematologic malignancies) or other malignancy within the last 12 months except non-melanoma skin cancer or cervical intraepithelial neoplasia.
  • Prior or current therapy:
  • Hydroxyurea or other oral medications to reduce blast count within 72 hours before the first dose of study drug
  • Treatment with an investigational agent within 14 days before the first dose of study drug, or not recovered from all acute effects of previous investigational therapy
  • Last treatment was with a drug of long elimination half-life (e.g. enasidenib), as such a wash out period 5x elimination half-life is necessary prior to enrollment
  • For patients who have undergone hematopoietic stem cell transplantation (HSCT), procedure-related medications (e.g. immunosuppressive therapy) administered within 2 weeks prior to first dose of study drug.
  • Any medical, psychological, or social condition that may interfere with study participation or compliance or may compromise the patient's safety in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

Arnon Nagler, MD contact

972-3-530-58-30

Arnon.Nagler@sheba.health.gov.il

Israel1 site, 1 recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 57261

    Arnon Nagler, M.D., +97235305830, Arnon.Nagler@sheba.health.gov.il

    M.D.

    Recruiting

Other trials in Israel

About this study

Official title: An Open-label, Phase II, Two-stage, Study of Bisantrene(Xantrene) in Combination With Fludarabine and Clofarabine as Salvage Therapy for Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

An Open-label, Phase II, Two-stage, Study of Xantrene® (Bisantrene) in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) Lead-in stage: up to 12 (up to 2 cohorts in a 3+3 dose escalation design) Efficacy stage: up to 17 (Simon 2-stage design 9+8)

Study Objectives:

Read more
  • Confirm safety and tolerability of the combination regimen
  • Time to response with combination treatment
  • Overall survival

The treatment regimen will comprise daily IV infusion of Fludarabine (Flu), Clofarabine (Clo) and Bisantrene (Xan) administered via central venous line and controlled-rate infusion pump with a 1-hour break between each agent infusion, amounting to a total of 6 hours for each daily FluCloXan treatment in the following sequence:

  • First, infusion over 60 minutes of Fludarabine (Flu) at 10 mg/m2
  • Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes
  • Followed by infusion of Bisantrene (Xan) at 250 mg/m2 over 2 hours. One cycle will comprise daily IV infusion of the combination treatment course for 4 or 5 consecutive days and rest period to between Day 30 and Day 42, based on patient performance and disease status.
Being tested
Bisantrene, Fludarabine, Clofarabine
Keywords
AML, Resistance relapsing ,Anti Leukemic effect , Bisantrene
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

    Combined escalated dose chemotherapy

  • FludarabineDrug

    Combined escalated dose chemotherapy

  • ClofarabineDrug

    Combined escalated dose chemotherapy

Study groups in NCT04989335
Study groupRoleWhat they receive
Bisantrene combined with Fludarabine and ClofarabineExperimentalBisantrene 250 mg at final concentration of 0.5 mg/mL will be administrated by intravenous (IV) infusion, delivered by a controlled-rate programmable pump via a central line over 2 hours. Fludarabine (generic) and Clofarabine (generic) are commercially available as injection for intravenous infusion. The treatment regimen will comprise daily IV infusion of Fludarabine (Flu), Clofarabine (Clo) and Bisantrene (Xan) administered via central venous line and controlled-rate infusion pump with a 1-hour break between each agent infusion, amounting to a total of 6 hours for each daily FluCloXan treatment in the following sequence: * First, infusion over 60 minutes of Fludarabine (Flu) at 10 mg/m2 * Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes * Followed by infusion of Bisantrene (Xan) at 250 mg/m2 over 2 hours.
Receives: Drug: Bisantrene; Drug: Fludarabine; Drug: Clofarabine

What is being measured

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

  1. The recommended Phase 2 dose (RP2D) , assessed by the number of treatment days of FluCloXan

    Measured: 12 months

  2. The maximum tolerated dose (MTD) of Bisantre in mg per day

    To evaluate safety and tolerability

    Measured: 12 months

  3. The overall response rate (ORR)

    Overall Response Rate (ORR) defined as the proportion of patients with complete remission (CR) and complete remission with incomplete blood count recovery (CRi) between Day 30 to Day 42.

    Measured: between Day 30 to Day 42.

Secondary outcomes (3)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    Confirm safety and tolerability of the combination regimen.

    Measured: 12 months

  2. Time of respons in months

    Number of months for each patient with no evidence of diseases.

    Measured: 12 months

  3. Overall survival

    Median surviving months for each patients.

    Measured: 12 months

Timeline

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

  1. First posted4 Aug 2021
  2. Study start2 Aug 2021
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04989335
Sponsor's protocol ID
RAC-002
Status last verified
Nov 2023
First submitted
7 Jul 2021
Last updated
28 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bisantrene, Fludarabine and Clofarabine in people with Myelogenous Leukemia, Acute, 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 8 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Arnon Nagler, MD (972-3-530-58-30, Arnon.Nagler@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The recommended Phase 2 dose (RP2D) , assessed by the number of treatment days of FluCloXan (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT04989335.

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 28 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.

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