A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FL… (NCT05876832) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE)
312 participantsStarted 2023-06-15
Plain-language summary
The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR/CRh rate in these subjects。
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age≥18 years old.
✓. Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.
✓. Subject is refractory to or relapsed after prior AML therapy (with or without hematopoietic stem cell transplant ):
✓. Patient is positive for FLT3-ITD mutation in bone marrow or whole blood.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
✓. Expected survival ≥12 weeks .
✓. Patient must meet the following criteria as indicated on the clinical laboratory tests:
✓. Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first study drug administration.Female patients of childbearing potential and male must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug.
Exclusion criteria
✕. Patient was diagnosed as acute promyelocytic leukemia (APL), or Philadelphia chromosome（BCR-ABL）-positive leukemia (chronic myelogenous leukemia in blast crisis).
✕. Patients who received live vaccine (including live attenuated vaccine) within 4 weeks before randomization and/or planed to receive live vaccine after enrollment.
What they're measuring
1
Interim analysis: Complete remission(CR)/CR with partial hematologic recovery(CRh) rate in the experimental group.
. Presence of FLT3-tyrosine kinase domain(TKD) mutation.
✕. Patients were prior failed adequate treatment with FLT3 inhibitors.
✕. AML with Central Nervous System Leukemia.
✕. Patient has AML secondary to prior chemotherapy for other neoplasms, except for MDS.
✕. Patients with other malignant tumors past or present,unless whose Disease-free survival period≥5 years.Non-melanin skin cancer, carcinoma in situ, or cervical intraepithelial neoplastic lesions with completed radical treatment (regardless of disease-free survival),and subjects with prostate cancer confined to the prostate and with no evidence of disease recurrence or progression,if they have started hormonal therapy or have undergone surgery to remove the malignancy or have undergone radical radiotherapy,will be eligible for the study.