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Bisantrene for Relapsed /Refractory AML

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ClinicalTrials.gov Identifier: NCT03820908
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
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 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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)
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2022


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

  2. 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.



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

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.


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 ClinicalTrials.gov identifier (NCT number): NCT03820908


Locations
Israel
Chaim Sheba Medical Center
Ramat Gan, Israel, 57261
Sponsors and Collaborators
Sheba Medical Center
Race Oncology Ltd

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
ClinicalTrials.gov Identifier: NCT03820908     History of Changes
Other Study ID Numbers: 5792-18 - SMC
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bisantrene
Antibiotics, Antineoplastic
Antineoplastic Agents