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

NCT ID: NCT05805072

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-06-30

Brief 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

Study Design

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

Study Groups

Selinexor+HAAG±HMA

Group Type: EXPERIMENTAL

Selinexor

Intervention Type: DRUG

Selinexor 60 mg/day, orally on d1,4,8,11

Homoharringtonine

Intervention Type: DRUG

Homoharringtonine 1 mg/day intravenously on days 3 to 9

Cytarabine

Intervention Type: DRUG

cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9

Aclacinomycin

Intervention Type: DRUG

aclacinomycin 10 mg/day intravenously on days 3 to 6

Granulocyte Colony-Stimulating Factor

Intervention Type: DRUG

granulocyte colony-stimulating factor 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram,

Decitabine

Intervention Type: DRUG

Decitabine 20 mg/m2/day intravenously on days 1 to 5.

Azacitidine

Intervention Type: DRUG

Azacitidine 20 mg/m2/day subcutaneously on days 1 to 7

Interventions

Selinexor

Selinexor 60 mg/day, orally on d1,4,8,11

Intervention Type: DRUG

Homoharringtonine

Homoharringtonine 1 mg/day intravenously on days 3 to 9

Intervention Type: DRUG

Cytarabine

cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9

Intervention Type: DRUG

Aclacinomycin

aclacinomycin 10 mg/day intravenously on days 3 to 6

Intervention Type: 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,

Intervention Type: DRUG

Decitabine

Decitabine 20 mg/m2/day intravenously on days 1 to 5.

Intervention Type: DRUG

Azacitidine

Azacitidine 20 mg/m2/day subcutaneously on days 1 to 7

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men and women aged ≥18 years.

2. Diagnosis of AML (defined according to the 5th of the World Health Organization [WHO] 2022 criteria) of any type except for acute promyelocytic leukemia (APL; AML M3)and the following conditions were met: Relapsing or refractory AML

3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

4. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for six months after their last dose of medication.

5. Patients whose expecting survival time will be more than 3 months.

6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

Exclusion Criteria

1. AML transformed from chronic myeloid leukemia.

2. Patients with APL/AML M3.

3. Presence of CNS leukemia.

4. Uncontrolled infection or other serious disease.

5. Unstable cardiovascular function: Cardiac ejection fraction (EF)<0.5, or congestive heart failure (CHF) of NYHA Class ≥ 2.

6. Unstable Liver and kidney function:TBLL≥2.0 mg/dl, AST≥3×ULN, Ccr≥50 ml/min, SpO2<92%.

7. Known human immunodeficiency virus (HIV) infection.

8. Active hepatitis B or hepatitis C infection.

9. Pregnant and lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.

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

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

Selinexor+HAAG+HMA

Identifier Type: -

Identifier Source: org_study_id