Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/L… (NCT04446130) | Clinical Trial Compass
UnknownPhase 3
Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients
China100 participantsStarted 2019-01-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of decitabine combined with HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and ALL/LBL with myeloid or stem cell markers.
Who can participate
Age range15 Years – 60 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed ETP-ALL/LBL, T/M-MPAL according to the 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia, and T-ALL/LBL with one or more of the myeloid or stem cell markers (CD34, CD117, HLADR, CD13, CD33, CD11b or CD65) on at least 25% of lymphoblasts.
✓. Age 15-60.
✓. Eastern Cooperative Oncology Group (ECOG) score: 0-2.
✓. No history of previous chemotherapy or target therapy.
✓. Provide informed consent.
Exclusion criteria
✕. Patients with another malignant disease.
✕. Patients has participated in or participating in other clinical trials.
✕. Patients with uncontrolled active infection.
✕. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
✕. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
✕. Patients with creatinine clearance rate \< 50ml/min.
✕. Patients with active hepatitis B or hepatitis C infection.
✕
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Day 28-35 of induction course
Trial details
NCT IDNCT04446130
SponsorThe First Affiliated Hospital of Soochow University