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

Phase 3

• 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

• Registration Number: NCT04446130
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Last Update Submitted: 2020-06-22
• Study First Posted: 2020-06-24
• Last Update Posted: 2020-06-24
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decitabine combined with HAAG Regimen	Decitabine combined with HAAG Regimen	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Day 28-35 of induction course	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 Outcome Measures

Name	Time	Method
Cumulative incidence of relapse(CIR)	4 years	time from achievement of a remmission to the first relapse
Overall survival (OS)	4 years	time from randomization to death from any cause
Number of adverse events	3 years	adverse events are evaluated with CTCAE V5.0.
Leukemia-free survival (LFS)	4 years	time from randomization to the first relapse or death

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China