Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bisantrene

Anti-Bacterial Agents

Antibiotics, Antitubercular

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

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

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 .

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).

Bisantrene for Relapsed /Refractory AML

Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)

Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.

Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.

Race Oncology Ltd

Sheba Medical Center

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

Fludarabine

Fludarabine phosphate

Clofarabine

Antimetabolites

Bisantrene 250 mg at final concentration of 0.5 mg/mL will be administrated by intravenous (IV) infusion, delivered by a controlled-rate programmable pump via a central line over 2 hours.

Fludarabine (generic) and Clofarabine (generic) are commercially available as injection for intravenous infusion.

The treatment regimen will comprise daily IV infusion of Fludarabine (Flu), Clofarabine (Clo) and Bisantrene (Xan) administered via central venous line and controlled-rate infusion pump with a 1-hour break between each agent infusion, amounting to a total of 6 hours for each daily FluCloXan treatment in the following sequence:

* First, infusion over 60 minutes of Fludarabine (Flu) at 10 mg/m2
* Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes
* Followed by infusion of Bisantrene (Xan) at 250 mg/m2 over 2 hours.

Arnon Nagler, MD

Arnon Nagler, M.D.

M.D.

An Open-label, Phase II, Two-stage, Study of Xantrene® (Bisantrene) in combination with Fludarabine and Clofarabine as Salvage Therapy for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) Lead-in stage: up to 12 (up to 2 cohorts in a 3+3 dose escalation design) Efficacy stage: up to 17 (Simon 2-stage design 9+8)

Study Objectives:

* Confirm safety and tolerability of the combination regimen
* Time to response with combination treatment
* Overall survival

The treatment regimen will comprise daily IV infusion of Fludarabine (Flu), Clofarabine (Clo) and Bisantrene (Xan) administered via central venous line and controlled-rate infusion pump with a 1-hour break between each agent infusion, amounting to a total of 6 hours for each daily FluCloXan treatment in the following sequence:

* First, infusion over 60 minutes of Fludarabine (Flu) at 10 mg/m2
* Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes
* Followed by infusion of Bisantrene (Xan) at 250 mg/m2 over 2 hours. One cycle will comprise daily IV infusion of the combination treatment course for 4 or 5 consecutive days and rest period to between Day 30 and Day 42, based on patient performance and disease status.

Bisantrene Combination for Resistant AML

An Open-label, Phase II, Two-stage, Study of Bisantrene(Xantrene) in Combination With Fludarabine and Clofarabine as Salvage Therapy for Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

To determine the MRD status of patients post completion of FluCloXan. MRD will be asset in patients with defiant mutations by Polymerase Chain Techniques(PCR).

Overall Response Rate (ORR) defined as the proportion of patients with complete remission (CR) and complete remission with incomplete blood count recovery (CRi) between Day 30 to Day 42.

Confirm safety and tolerability of the combination regimen.

Number of months for each patient with no evidence of diseases.

Median surviving months for each patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bisantrene for Relapsed /Refractory AML	NCT03820908	Acute Myelogeno... Allogeneic Stem...	Bisantrene	18 Years -	Sheba Medical Center
Bisantrene Combination for Resistant AML	NCT04989335	Myelogenous Leu...	Bisantrene Fludarabine Clofarabine	18 Years - 65 Years	Sheba Medical Center

Spots Global Cancer Trial Database for bisantrene

Every month we try and update this database with for bisantrene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bisantrene

Every month we try and update this database with for bisantrene cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bisantrene cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.