Clinical trial NCT06712121: Venetoclax and Decitabine in R/R T-ALL
Official title: A Phase 2 Clinical Trial to Evaluate the Efficacy of VEnetoclax and DEciTabine in Relapsed/Refractory Adult T-acute Lymphoblastic lEukemia/Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: T Lymphoblastic Leukemia/Lymphoma
Keywords: T lymphoblastic leukemia/lymphoma
venetoclax
decitabine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Hematology
First posted: 2024-12-02
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 \&lt;50,000/uL (reducing white blood cell count through hydroxyurea or leukapheresis prior to trial enrollment is allowed)
* At the time of screening, a calculated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formulas, or creatinine ≤ 1.4, total bilirubin ≤ 3.0 mg/dL, and AST and ALT \&lt; x5 upper limit of normal (ULN) (however, if bilirubin elevation is due to Gilbert\&#39;s syndrome or liver enzyme elevation is due to infiltration of leukemia/lymphoma, enrollment may be allowed even if the above conditions are exceeded)
* Individuals who agree to the following contraceptive measures for a period of 3 months during treatment and for 3 months after completion:

Exclusion Criteria:

* 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.
* Individuals with active leukemia involving the central nervous system.
* Individuals with a cancer type other than T-lymphoblastic leukemia/lymphoma that requires current active treatment (participants with a cancer type that has already been cured or is in a slow-progressing state without treatment, as determined by surgery/radiation/chemotherapy, may participate under the consultation of the clinical trial investigator).
* Individuals with active human immunodeficiency virus (HIV) infection, hepatitis B/hepatitis C infection (participants without evidence of viral particles through PCR testing may be enrolled with the consent of an infectious disease specialist or hepatologist).
* Uncontrolled bleeding.
* Uncontrolled infection (bacterial, fungal, viral).
* Uncontrolled mental illness.
* Individuals who do not understand the informed consent or have difficulty in adequate communication, making them inappropriate for participation in the clinical trial.
* Cases where the investigator judges that patient evaluation may be hindered or participation in the clinical trial is not appropriate.
* Individuals who have a negative attitude towards participating in the clinical trial or who are unwilling to comply with the treatment and specimen collection schedule specified in the study protocol.

Primary outcomes:
measure: The rate of composite Complete remission
timeFrame: 1 year
Secondary outcomes:
measure: Composite overall response rate
timeFrame: 1 year
measure: Clinical benefit rate
timeFrame: 1 year
measure: Duration of response
timeFrame: 1 year
measure: Bridging to allogeneic hematopoietic stem cell transplantation (HSCT)
timeFrame: 1 year
measure: Progression-free survival (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: