Status:
UNKNOWN
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
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Henan Cancer Hospital
Shandong Provincial Hospital
Conditions:
Induction Chemotherapy
Acute T-Lymphocytic Leukemia
Eligibility:
All Genders
15-60 years
Phase:
PHASE3
Brief 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 myelo...
Detailed Description
This is a phase 3, open label, single arm, multi-center study in newly diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL patients who have myeloid or stem cell markers. The patients will receive decitabine ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients with HIV infection.
- Patients with active tuberculosis infection.
- Patients with uncontrolled active bleeding.
- Patients with a history of allergy to experimental drugs.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04446130
Start Date
January 1 2019
End Date
January 1 2024
Last Update
June 24 2020
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006