Bisantrene for Relapsed /Refractory AML

Study Overview
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Brief Summary
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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 .

Official Title
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Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)

Conditions
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Acute Myelogenous Leukemia, Allogeneic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Bisantrene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bisantrene<br>patients will receive bisantrene 250mg/m2/d for 7 days | Drug: Bisantrene<br>* The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival will be calculated from the day of bisantrene administration until death or last follow-up. | 24 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsed AML, refractory AML