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

Last updated: June 22, 2020
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT04446130
DAC-HAAG-03
  • Ages 15-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Newly diagnosed ETP-ALL/LBL, T/M-MPAL according to the 2016 revision to the WHOclassification of myeloid neoplasms and acute leukemia, and T-ALL/LBL with one or moreof the myeloid or stem cell markers (CD34, CD117, HLADR, CD13, CD33, CD11b or CD65) onat 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

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 gradeIII/IV cardiovascular dysfunction according to the New York Heart AssociationClassification.

  5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upperlimit 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 theenrollment.

Study Design

Total Participants: 100
Study Start date:
January 01, 2019
Estimated Completion Date:
January 01, 2024

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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