Bisantrene for Relapsed /Refractory AML

NCT03820908 | Completed Phase 2

• 1 other identifier: 5792-18 - SMC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

relapsed AML; refractory AML

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Bisantrene

EXPERIMENTAL

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

Drug: Bisantrene

Interventions

Bisantrene DRUG

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

Bisantrene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
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• Pregnant or lactating females
• Known human immunodeficiency virus infection
• Active hepatitis B or C infection

Sponsors & Collaborators

• Sheba Medical Center: lead
• Race Oncology Ltd: collaborator

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, 57261, Israel

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

bisantrene

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: 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).

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 29, 2019
• Study Start: July 18, 2019
• Primary Completion: May 19, 2020
• Study Completion: July 22, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

IL (1)