NCT05805072

Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients

An Open Label, Single Arm, Single-Center Exploratory Study to Evaluate the Efficacy and Safety of Selinexor and HAAG +/- HMA in Relapsed/Refractory Acute Leukemia (AML) Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.

Detailed description

This protocol corresponds to a single-center, open-label, single-arm, exploratory study designed to determine the efficacy and safety of the combination of selinexor with HAAG +/- HMA in patients with relapsed or refractory AML. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment according to patient's wishes. Each cycle of treatment will compromise 2 weeks of selinexor treatment, and at least two weeks off treatment. The new cycle will not start if there is an ongoing grade 3 or higher non-hematologic toxicity or persistent grade 3 neutropenia in patients achieving CR. Study design allows 20 patients. Treatment will consist of selinexor 60 mg/day orally on d1,4,8,11, HHT 1 mg/day intravenously on days 3 to 9, cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9, aclacinomycin 10 mg/day intravenously on days 3 to 6, G-CSF 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram, DAC 20 mg/m2/day intravenously on days 1 to 5. Whether to add hypomethylating agents was decided by the investigator according to the patient's disease degree and tolerance status. If patients had previously been exposed to decitabine, azacitidine will added this regimen, AZA 20 mg/m2/day subcutaneously on days 1 to 7.

Conditions

• Relapsed/Refractory AML

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor 60 mg/day, orally on d1,4,8,11
DRUG	Homoharringtonine	Homoharringtonine 1 mg/day intravenously on days 3 to 9
DRUG	Cytarabine	cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9
DRUG	Aclacinomycin	aclacinomycin 10 mg/day intravenously on days 3 to 6
DRUG	Granulocyte Colony-Stimulating Factor	granulocyte colony-stimulating factor 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram,
DRUG	Decitabine	Decitabine 20 mg/m2/day intravenously on days 1 to 5.
DRUG	Azacitidine	Azacitidine 20 mg/m2/day subcutaneously on days 1 to 7

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-04-07
• Last updated: 2023-05-06

Locations

1 site across 1 country: China