Trials / Unknown
UnknownNCT04446130
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
A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety 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
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Academic / Other
- Sex
- All
- Age
- 15 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Induction Chemotherapy
- Acute T-Lymphocytic Leukemia
- T-cell Lymphoblastic Lymphoma Leukemia
- T-cell/Myeloid Mixed Phenotype Acute Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2023-01-01
- Completion
- 2024-01-01
- First posted
- 2020-06-24
- Last updated
- 2020-06-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04446130. Inclusion in this directory is not an endorsement.