Overview

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

Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborators:
Changzhou No.2 People's Hospital
Henan Cancer Hospital
Shandong Provincial Hospital
Shenzhen People's Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Anhui Medical University
The Second People's Hospital of Huai'an
Treatments:
Decitabine
Criteria
Inclusion Criteria:

1. 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.

2. Age 15-60.

3. Eastern Cooperative Oncology Group (ECOG) score: 0-2.

4. No history of previous chemotherapy or target therapy.

5. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.

2. Patients has participated in or participating in other clinical trials.

3. Patients with uncontrolled active infection.

4. Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade
III/IV cardiovascular dysfunction according to the New York Heart Association
Classification.

5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper
limit of normal or bilirubin > 2.0 mg/dL.

6. Patients with creatinine clearance rate < 50ml/min.

7. Patients with active hepatitis B or hepatitis C infection.

8. Patients with HIV infection.

9. Patients with active tuberculosis infection.

10. Patients with uncontrolled active bleeding.

11. Patients with a history of allergy to experimental drugs.

12. Patients with other commodities that the investigators considered not suitable for the
enrollment.