Clinical trial · Interventional
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
NCT05805072CI-TRIAL-00066166unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory AML | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aclacinomycin | Drug | — | UNRESOLVED |
| Azacitidine | Drug | Azacitidine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| Granulocyte Colony-Stimulating Factor | Drug | — | UNRESOLVED |
| Homoharringtonine | Drug | Omacetaxine Mepesuccinate | ALIAS |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selinexor+HAAG±HMA
- interventionNames
- Drug: Selinexor
- Drug: Homoharringtonine
- Drug: Cytarabine
- Drug: Aclacinomycin
- Drug: Granulocyte Colony-Stimulating Factor
- Drug: Decitabine
- Drug: Azacitidine
Primary outcomes (1)
- measure
- Number of Participants With CR/CRi
- timeFrame
- End of cycle 1 and 2 (each cycle is 28 days)
- description
- 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
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.