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

Soochow University

Status and phase: Unknown; Phase 3

Conditions: T-cell Lymphoblastic Lymphoma Leukemia; Acute T-Lymphocytic Leukemia; T-cell/Myeloid Mixed Phenotype Acute Leukemia; Induction Chemotherapy

Treatments: Drug: Decitabine combined with HAAG Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT04446130

DAC-HAAG-03

Details and patient eligibility

About

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.

Full 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 combined with HAAG regimen in the induction treatment. The patients who respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with decitabine according to patient's wishes.

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Decitabine combined with HAAG Regimen

Experimental group

Description:

This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed T-ALL/LBL and T/M-MPAL patients.

Treatment:

Drug: Decitabine combined with HAAG Regimen