None listed
Conditions
Interventions
Drug : Decitabine 20 mg/m2 on days 1-7 of each cycle, Venetoclax 100 mg on day 1, 200 mg on day 2, and 400 mg on days 1-21 of each cycle beginning with cycle 3 (400 mg D1-21 beginning with cycle 2). D
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults = 19 years of age and < 80 years of age (2) Eastern Cooperative Oncology Group Performance Score (ECOG PS) = 2 (3) Diagnosed with T-cell acute lymphoblastic leukemia/lymphoma (T- lymphoblastic leukemia/lymphoma) according to 2016 World Health Organization diagnostic criteria (4) Have been diagnosed with T-cell acute lymphoblastic leukemia/lymphoma and have received at least one course of remission-inducing chemotherapy and achieved a complete remission, but subsequently relapsed (relapse); or (5) diagnosed with T-cell acute lymphoblastic leukemia/lymphoma Diagnosed with T-cell acute lymphoblastic leukemia/lymphoma and received one or more lines of remission-inducing chemotherapy, but failed to achieve complete remission. or relapsed and failed to achieve a complete remission despite a second remission-inducing chemotherapy regimen. who have failed to achieve a complete remission. (5) Patients with peripheral blood leukocytes <50,000/µL. (Patients who have received hydroxyurea, steroids, or leukapheresis to reduce leukocytes prior to study entry. to reduce the white blood cell count prior to enrollment in the study is permitted). (6) GFR = 30 mL/min calculated by the Cockcroft-Gault and MDRD method at the time of consideration for enrollment, and total bilirubin = 3.0 mg/dL and AST and ALT < x5 upper limit of normal (ULN) at the time of review for enrollment (Gilbert syndrome or if, in the investigator's judgment, the liver value abnormality is due to leukemic involvement) (7) Agree to use the following high-efficiency contraception during treatment and for 6 months after completion of treatment Female patients must be postmenopausal for at least 1 year or surgically sterilized (bilateral tubal ligation at least 3 months prior to study entry). undergone bilateral tubal ligation, bilateral oophorectomy, and/or hysterectomy at least 3 months prior to study entry). Are of childbearing potential, defined as being of non-childbearing potential, or are of childbearing potential and will be able to use the study drug for the entire study period and for a period of 90 days following the last Agree to practice an approved method of birth control for the entire study period and up to 90 days after dosing. - Examples of approved contraceptive methods in this study include a. Intrauterine device (IUD) b. Hormonal contraceptives associated with ovulation suppression (e.g., oral contraceptive pills, vaginal rings, or patches) that have been started at least 3 months prior to taking the study drug. The specific contraceptive method you will be using will be determined by your study healthcare provider c. Sexual partner has had a vasectomy. d. Complete abstinence from sexual intercourse if that is the patient's preferred lifestyle; periodic abstinence is not allowed e. Male patients must abstain from spermatorrhea for a period of up to 90 days after the last dose of study drug, as specified in the plan, including abstaining from must agree to follow one of the following methods of pregnancy avoidance as specified in the protocol, including abstaining from spermicide for up to 90 days after the last dose of study drug. Must agree to a. Surgically sterilized (vasectomy performed more than 6 months prior to Screening). b. The subject is using condoms and the female partner is using one of the approved contraceptive methods listed above. listed above. c. Complete abstinence from sexual intercourse with the female partner, if that is the patient's
Exclusion criteria
Exclusion criteria: 1) Complete response to prior therapy at the time of enrollment review (unless relapse or refractoriness is demonstrated by bone marrow or phase/histologic examination) (2) Previous use of venetoclax + decitabine combination for the treatment of T-cell acute lymphoblastic leukemia/lymphoma (3) Previous use of venetoclax plus decitabine regimen for the treatment of other malignancies (e.g., acute myeloid leukemia). Participants are eligible if it has been more than 1 year since the last treatment) (3) Pregnant or breastfeeding. - For women of childbearing potential, a negative pregnancy test must be demonstrated during the screening period (4) Treatment with an investigational drug or systemic cytotoxic antineoplastic agent within the past 2 weeks (5) Have uncontrolled progressive and active leukemic central nervous system involvement (6) Currently have a carcinoma other than T-cell acute lymphoblastic leukemia/lymphoma requiring active treatment (surgery/radiation/radiotherapy) (Patients who have already been cured by surgery/radiation/anti-cancer therapy, or who are not cured but have a slow natural progression without treatment. If you have carcinoma that has already been cured by surgery/radiation/anti-cancer treatment, or if you have carcinoma at a stage that is being monitored without treatment due to slow natural progression (7) Active HIV, B-cell carcinoma (7) Active HIV, hepatitis B, or hepatitis C (may participate if well controlled under the advice of an infectious disease specialist or hepatologist). well controlled under the advice of an infectious disease specialist or liver specialist) (8) Uncontrolled bleeding (9) Have an uncontrolled infection (bacterial, fungal, viral) (10) Have an uncontrolled psychiatric condition (11) Inability to understand the informed consent document or inability to communicate adequately, making participation in the study inappropriate (12) Any medical condition that, in the opinion of the investigator, interferes with the evaluation of the patient's response or makes participation in the study inappropriate. medical condition that, in the opinion of the investigator, may interfere with the evaluation of the patient's response or make participation in the study inappropriate (13) Have a medical condition that is adverse to participation in the study or is unwilling or unable to comply with the protocol treatment and testing schedule. unwillingness to comply with the treatment and examination schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow examination (bone marrow aspiration and biopsy) ;Image test(CT and/or PET/CT scan) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Yeop Shin
Seoul National University Hospital
Outcome results
None listed