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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820908
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
Race Oncology Ltd
Information provided by (Responsible Party):
Prof Arnon Nagler, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE January 24, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE July 18, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • Overall survival [ Time Frame: 36 months ]
    Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
  • Leukemia-free survival [ Time Frame: 36 months ]
    Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bisantrene for Relapsed /Refractory AML
Official Title  ICMJE Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)
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 .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Acute Myelogenous Leukemia
  • Allogeneic Stem Cell Transplantation
Intervention  ICMJE Drug: Bisantrene
The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.
Study Arms  ICMJE Experimental: Bisantrene
patients will receive bisantrene 250mg/m2/d for 7 days
Intervention: Drug: Bisantrene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820908
Other Study ID Numbers  ICMJE 5792-18 - SMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Arnon Nagler, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Race Oncology Ltd
Investigators  ICMJE Not Provided
PRS Account Sheba Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP