Venetoclax and Decitabine in R/R T-ALL
ConditionT Lymphoblastic Leukemia/Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older but less than 80 years
Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≤ 2
Confirmed diagnosis of T-cell lymphoblastic leukemia/lymphoma according to the 2016 World Health Organization criteria, with relapse or failure to achieve complete remission despite induction chemotherapy
Patients with peripheral blood leukocytes <50,000/uL (reducing white blood cell count through hydroxyurea or leukapheresis prior to trial enrollment is allowed)
Disqualifiers
Individuals in complete remission with previous treatment, if relapse or resistance is not confirmed by bone marrow examination or imaging/tissue examination.
Individuals who previously received venetoclax + decitabine treatment for T-lymphoblastic leukemia/lymphoma (participants who received venetoclax + decitabine treatment for a different type of cancer [e.g., acute myeloid leukemia] and have elapsed more than 1 year since the last treatment are allowed).
Pregnant or breastfeeding individuals.
Individuals who received systemic anticancer chemotherapy or participated in a clinical trial treatment within the past 2 weeks.
Trial design
Design model
Single group
Treatments tested in this trial
decitabine plus venetoclax
Drugdecitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: decitabine and venetoclax armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The 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 yearSecondary outcomes
1
Composite overall response rate
cORR: CR/CRh/CRi/MLFS+PR
Time frame
1 year2
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 year3
Duration of response
by months
Time frame
1 year4
Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)
by rate
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Korean Society of Hematology
Collaborator
Source ClinicalTrials.gov