Working… Menu

Bisantrene for Relapsed /Refractory AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03820908
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : August 7, 2020
Race Oncology Ltd
Information provided by (Responsible Party):
Prof Arnon Nagler, Sheba Medical Center

Brief 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 .

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Allogeneic Stem Cell Transplantation Drug: Bisantrene Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)
Actual Study Start Date : July 18, 2019
Actual Primary Completion Date : May 19, 2020
Actual Study Completion Date : July 22, 2020

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.

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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


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


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03820908

Layout table for location information
Chaim Sheba Medical Center
Ramat Gan, Israel, 57261
Sponsors and Collaborators
Sheba Medical Center
Race Oncology Ltd
Layout table for additonal information
Responsible Party: Prof Arnon Nagler, Arnon Nagler, M.D., M.Sc Professor of Medicine Tel Aviv University, Director Hematology Division BMT and Cord Blood Bank, Chair Israeli BMT Association, Chair of the ALWP of the EBMT, Co-Chair Scientific Council of the EBMT, Sheba Medical Center Identifier: NCT03820908    
Other Study ID Numbers: 5792-18 - SMC
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

Layout table for additional information
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
Keywords provided by Prof Arnon Nagler, Sheba Medical Center:
relapsed AML
refractory AML
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents