Bisantrene for Relapsed /Refractory AML

• ClinicalTrials.gov Identifier: NCT03820908
• Recruitment Status: Completed
• First Posted: January 29, 2019
• Last Update Posted: August 7, 2020
• Sponsor: Sheba Medical Center
• Collaborator: Race Oncology Ltd
• Information provided by (Responsible Party): Prof Arnon Nagler, Sheba Medical Center

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 .

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Israel

Chaim Sheba Medical Center

Ramat Gan, Israel, 57261

Sponsors and Collaborators

Sheba Medical Center

Race Oncology Ltd

More 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
• ClinicalTrials.gov Identifier: NCT03820908
• Other Study ID Numbers: 5792-18 - SMC
• First Posted: January 29, 2019
• Last Update Posted: August 7, 2020
• Last Verified: August 2020

• 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