Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
Beijing, 100071, China
Location status: Recruiting
Location contact
Bo Cai, MD
CONTACT
Bo Cai, MD
PRINCIPAL_INVESTIGATOR
Yangyang Lei, MD
CONTACT
NCT Number: NCT07078591
The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Beijing, 100071, China
Location status: Recruiting
Bo Cai, MD
CONTACT
Bo Cai, MD
PRINCIPAL_INVESTIGATOR
Yangyang Lei, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Given PO
Given SC
Given IV
Given IV
Given IV
HLA-mismatched donor GPBMC infusion
Time frame: Measured up to 4 years after the last participant is enrolled
OS is defined as the number of days from the date of initiation of treatment to the date of death.
Time frame: Measured up to 4 years after the last participant is enrolled
EFS is defined as the number of days from initiation of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.
Time frame: Measured up to 2 years after the last participant is enrolled
CR is defined as absolute neutrophil count > 1 × 109/L, platelet count > 100 × 109/L, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophil count <= 1 × 109/L or platelet count <= 100 × 109/L.
Time frame: Measured up to 2 years after the last participant is enrolled
PR is defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow, peripheral blood neutrophil count > 1 × 109/L, platelet count > 100 × 109/L, red cell transfusion independence.
Time frame: Measured up to 4 years after the last participant is enrolled
NRM is defined as the death without relapse.
Contact information is provided by the study sponsor or research team.
Bo Cai, MD
CONTACT
Yangyang Lei, MD
CONTACT
Beijing 302 Hospital
Other
Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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