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
  • participants needed
    100
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 19 February 2024

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.

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.

Details
Condition Chemotherapy, Chemotherapy, T-cell acute lymphoblastic leukemia, T-cell Lymphoblastic Lymphoma Leukemia, T-cell/Myeloid Mixed Phenotype Acute Leukemia
Age 15-60 years
Treatment Decitabine combined with HAAG Regimen
Clinical Study IdentifierNCT04446130
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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