Relapsed/Refractory AML Clinical Trial
Official title:
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
Verified date | March 2023 |
Source | The First Affiliated Hospital of Soochow University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants With ORR | ORR =CR+CRi+PR+MLFS
PR: Absolute Neutrophil count (ANC) >1.0x10^9/L, Platelet count >100x10^9/L, at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods. MLFS: Bone marrow blasts <5%, no Auer rods, no evidence of extramedullary disease |
End of cycle 1 and 2 (each cycle is 28 days) | |
Secondary | Percentage of Patients Transplanted After Induction Therapy (Stem Cell Transplantation) | Rate of ASCT: Percentage of patients being transplanted after induction therapy (stem cell transplantation) | 1-2 induction cycles (4 - 8 weeks) | |
Secondary | Progression-Free Survival | Progression-free survival (PFS): was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse.
Disease progression was defined as presence of >50% increase in bone marrow blasts to a level of at least 50% and/or a doubling of the percentage of peripheral blood blasts to a level of at least 50%. |
Time from registration to event, max 2 years | |
Secondary | Overall Survival | Overall survival (OS) was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up. | Time from registration to event, max 2 years | |
Secondary | Number of adverse events | Adverse events are evaluated with CTCAE V5.0 | End of cycle 1 and 2 (each cycle is 28 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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