search
Back to results

Bisantrene for Relapsed /Refractory AML

Primary Purpose

Acute Myelogenous Leukemia, Allogeneic Stem Cell Transplantation

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Bisantrene
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring relapsed AML, refractory AML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bisantrene

Arm Description

patients will receive bisantrene 250mg/m2/d for 7 days

Outcomes

Primary Outcome Measures

Overall survival
Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2019
Last Updated
August 6, 2020
Sponsor
Sheba Medical Center
Collaborators
Race Oncology Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03820908
Brief Title
Bisantrene for Relapsed /Refractory AML
Official Title
Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
May 19, 2020 (Actual)
Study Completion Date
July 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Race Oncology Ltd

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Allogeneic Stem Cell Transplantation
Keywords
relapsed AML, refractory AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bisantrene
Arm Type
Experimental
Arm Description
patients will receive bisantrene 250mg/m2/d for 7 days
Intervention Type
Drug
Intervention Name(s)
Bisantrene
Intervention Description
The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
Time Frame
24 months
Title
Leukemia-free survival
Description
Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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 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 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.
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
57261
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Bisantrene for Relapsed /Refractory AML

We'll reach out to this number within 24 hrs