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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

NCT04446130 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-24

No results posted yet for this 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.

Conditions

  • Induction Chemotherapy
  • Acute T-Lymphocytic Leukemia
  • T-cell Lymphoblastic Lymphoma Leukemia
  • T-cell/Myeloid Mixed Phenotype Acute Leukemia

Interventions

DRUG

Decitabine combined with HAAG Regimen

Decitabine :20mg/m2/d,d1\~5, intravenous infusion; Homoharringtonine :1mg/d,d3\~16,intravenous infusion; Aclarubicin :10mg/d, d3\~d10, intravenous infusion; Cytarabine :10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection

Sponsors & Collaborators

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Shenzhen People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Changzhou No.2 People's Hospital

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Xiaowen Tang, Ph.D. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-01-01
Completion
2024-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446130 on ClinicalTrials.gov