Bisantrene for Relapsed /Refractory AML

Acute Myelogenous Leukemia Clinical Trial

Official title:

Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820908
• Other study ID #: 5792-18 - SMC
• Status: Completed
• Phase: Phase 2
• Start date: July 18, 2019
• Est. completion date: July 22, 2020

Study information

• Verified date: August 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 22, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Allogeneic Stem Cell Transplantation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Bisantrene
The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Race Oncology Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.	24 months
Primary	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.	24 months