Bisantrene for Relapsed /Refractory AML

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 .

Study Overview

• Status: Completed
• Conditions: Acute Myelogenous Leukemia; Allogeneic Stem Cell Transplantation
• Intervention / Treatment: Drug: Bisantrene

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 57261
    • Chaim Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study.

Disease-related:

1. Patients with Rel/Ref/AML
2. Adequate birth control in fertile patients.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Demographic:

1. Age ≥ 18 years and willing and able to comply with the protocol requirements
2. Life expectancy ≥ 3 months Ethical/Other
3. Written informed consent in accordance with federal, local, and institutional guidelines.
4. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.
5. Male subjects must agree to practice contraception

Exclusion Criteria:

• Disease-related

  1. Patients with other type of basic disease other than Rel/Ref AML.
  2. Patients with respiratory failure (DLCO < 30%).
  3. Patients with active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
  4. Patients with > grade II liver renal toxicity.
  5. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
  6. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
  7. Creatinine > 2.0 mg/dl
  8. ECOG-Performance status > 2
  9. CNS disease involvement
  10. Severe pleural effusion and ascites. Concurrent Conditions
  1. Pregnant or lactating females
  2. Known human immunodeficiency virus infection
  3. Active hepatitis B or C infection
  4. 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
  5. 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
  6. 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.
  7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bisantrene; patients will receive bisantrene 250mg/m2/d for 7 days	Drug: Bisantrene; The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.	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.	24 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Race Oncology Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): May 19, 2020
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 27, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: relapsed AML; refractory AML
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Antineoplastic Agents; Antibiotics, Antineoplastic; Bisantrene
• Other Study ID Numbers: 5792-18 - SMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No