Bisantrene for Relapsed /Refractory AML

NCT ID: NCT03820908

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2020-07-22

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 .

Conditions

Acute Myelogenous Leukemia; Allogeneic Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bisantrene

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

Group Type: EXPERIMENTAL

Bisantrene

Intervention Type: DRUG

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

Interventions

Bisantrene

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Race Oncology Ltd

INDUSTRY

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaim Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

5792-18 - SMC

Identifier Type: -

Identifier Source: org_study_id