Clinical trial · Interventional
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
NCT04446130CI-TRIAL-00045657unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute T-Lymphocytic Leukemia | T Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Induction Chemotherapy | — | UNRESOLVED | — |
| T-cell Lymphoblastic Lymphoma Leukemia | — | UNRESOLVED | — |
| T-cell/Myeloid Mixed Phenotype Acute Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine combined with HAAG Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine combined with HAAG Regimen
- 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.
- interventionNames
- Drug: Decitabine combined with HAAG Regimen
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Day 28-35 of induction course
- description
- ORR includes complete remission (CR), CR with incomplete hematologic recovery (CRi) and partial remission (PR). CR was defined as \< 5% bone marrow blasts in an aspirate with spicules and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.