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

NCT05805072 | Unknown

• 1 other identifier: Selinexor+HAAG+HMA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed/Refractory AML

Outcome Measures

Primary Outcomes (1)

• Number of Participants With CR/CRi

  Number of Participants With CR/CRi CR: Absolute Neutrophil count (ANC) \>1.0x10\^9/L, Platelet count \>100x10\^9/L, Bone marrow blasts \<5%, no Auer rods, no evidence of extramedullary disease. CRi: Same as CR, but ANC may be \<1.0x10\^9/L and/or Platelet count \<100x10\^9/L

  End of cycle 1 and 2 (each cycle is 28 days)

Secondary Outcomes (5)

• Number of Participants With ORR

  End of cycle 1 and 2 (each cycle is 28 days)

• Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation)

  1-2 induction cycles (4 - 8 weeks)

• Progression-Free Survival

  Time from registration to event, max 2 years

• Overall Survival

  Time from registration to event, max 2 years

• Number of adverse events

  End of cycle 1 and 2 (each cycle is 28 days)

Study Arms (1)

Selinexor+HAAG±HMA

EXPERIMENTAL

Drug: Selinexor; Drug: Homoharringtonine; Drug: Cytarabine; Drug: Aclacinomycin; Drug: Granulocyte Colony-Stimulating Factor; Drug: Decitabine; Drug: Azacitidine

Interventions

Selinexor DRUG

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

Selinexor+HAAG±HMA

Homoharringtonine DRUG

Homoharringtonine 1 mg/day intravenously on days 3 to 9

Selinexor+HAAG±HMA

Cytarabine DRUG

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

Selinexor+HAAG±HMA

Aclacinomycin DRUG

aclacinomycin 10 mg/day intravenously on days 3 to 6

Selinexor+HAAG±HMA

Granulocyte Colony-Stimulating Factor 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,

Selinexor+HAAG±HMA

Decitabine DRUG

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

Selinexor+HAAG±HMA

Azacitidine DRUG

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

Selinexor+HAAG±HMA

Eligibility Criteria

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

You may qualify if:

• Men and women aged ≥18 years.
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• 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.
• Patients whose expecting survival time will be more than 3 months.
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

You may not qualify if:

• AML transformed from chronic myeloid leukemia.
• Patients with APL/AML M3.
• Presence of CNS leukemia.
• Uncontrolled infection or other serious disease.
• Unstable cardiovascular function: Cardiac ejection fraction (EF)\<0.5, or congestive heart failure (CHF) of NYHA Class ≥ 2.
• Unstable Liver and kidney function:TBLL≥2.0 mg/dl, AST≥3×ULN, Ccr≥50 ml/min, SpO2\<92%.
• Known human immunodeficiency virus (HIV) infection.
• Active hepatitis B or hepatitis C infection.
• Pregnant and lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

selinexor; Homoharringtonine; Cytarabine; aclacinomycins; Granulocyte Colony-Stimulating Factor; Decitabine; Azacitidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Aza Compounds; Organic Chemicals; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)