The goal of this phase 2 clinical trial is to test the efficacy of decitabine and venetoclax combination chemotherapy in relapsed or refractory adult T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma. This study use a modified regimen of decitabine and venetoclax.
Our study is conducted in collaboration with Korean adult acute lymphoblastic leukemia working party (KALLWP) and consortium for improving survival of lymphoma (CISL). This study recruits adult patients with R/R T-ALL/LBL and treated with 7-day decitabine plus 3 weeks of venetoclax up to 12 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days
Seoul National University Bundang Hospital
Seongnam-si, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGThe rate of composite Complete remission
CR: complete remission CRh: complete remission with partial hematologic recovery CRi: complete remission with incomplete hematologic recovery MLFS: morphologic leukemia-free state
Time frame: 1 year
Composite overall response rate
cORR: CR/CRh/CRi/MLFS+PR
Time frame: 1 year
Clinical benefit rate
CR: complete remission CRh: complete remission with partial hematologic recovery CRi: complete remission with incomplete hematologic recovery MLFS: morphologic leukemia-free state PR: partial remission stable disease
Time frame: 1 year
Duration of response
by months
Time frame: 1 year
Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)
by rate
Time frame: 1 year
Progression-free survival (PFS)
by months
Time frame: 1 year
Overall survival (OS)
by months
Time frame: 1 year
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