Clinical trial NCT04446130: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Induction Chemotherapy
Acute T-Lymphocytic Leukemia
T-cell Lymphoblastic Lymphoma Leukemia
T-cell/Myeloid Mixed Phenotype Acute Leukemia
Keywords: T-ALL/LBL
T/M-MPAL
Decitabine combined with HAAG
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Henan Cancer Hospital
name: Shandong Provincial Hospital
name: Shenzhen People's Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Changzhou No.2 People's Hospital
name: The Second People's Hospital of Huai'an
First posted: 2020-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Day 28-35 of induction course
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 4 years
measure: Leukemia-free survival (LFS)
timeFrame: 4 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 4 years
measure: Number of adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: