Adult refractory/relapsed acute T-lymphoblastic leukemia (T-ALL)
Conditions
Interventions
Experimental group:Treatment with PD-1 inhibitors combined with venetoclax +CAG regimens
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Met the T-ALL diagnosis before enrollment (for specific diagnostic criteria, see the attachment); 3. Refractory T-ALL (newly diagnosed T-ALL that fails to achieve remission after treatment with one standard regimen) or recurrent T-ALL (bone marrow blasts exceed 5% again after remission, and the morphology and immunophenotype of leukemia cells are consistent with T-ALL); 4. The performance status score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points. 5. Expected survival period >=3 months; 6. During the screening period, there were no organ function abnormalities that restricted the use of this scheme. 7. Understand this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with refractory/relapsed T-ALL who are not suitable for or whose economic conditions restrict the use of PD-1 and venetoclax for treatment; 2. Diseases that may limit patients' participation in this trial due to abnormal functions of organs such as the heart, lungs, liver, and kidneys (such as advanced infections, uncontrolled diabetes, severe heart failure or angina pectoris, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, severe renal insufficiency, etc.); 3. There has been a history of other malignant tumors within the past five years; 4. Known HIV infection, active hepatitis B virus (HbsAg positive and HBV-DNA higher than the upper limit of the detection value) or active hepatitis C virus (anti-HCV antibody positive or HCV RNA positive) infection; 5. Inability to understand or comply with the research protocol; 6. Patients under 18 years old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mCRc; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Hematological and non-hematological adverse reactions;minimal residual disease, MRD;Disease-free survival, DFS; | — |
Countries
China
Contacts
Public ContactWang Shaoyuan
Fujian Medical University Union Hospital
Outcome results
None listed