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

Sponsor

The First Affiliated Hospital of Soochow University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04446130

Collaborator

Henan Cancer Hospital (Other), Shandong Provincial Hospital (Other), Shenzhen People's Hospital (Other), The First Affiliated Hospital of Anhui Medical University (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), Changzhou No.2 People's Hospital (Other), The Second People's Hospital of Huai'an (Other)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Induction Chemotherapy Acute T-Lymphocytic Leukemia T-cell Lymphoblastic Lymphoma Leukemia T-cell/Myeloid Mixed Phenotype Acute Leukemia	Drug: Decitabine combined with HAAG Regimen	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Age 15-60.
Eastern Cooperative Oncology Group (ECOG) score: 0-2.
No history of previous chemotherapy or target therapy.
Provide informed consent.

Exclusion Criteria:

Patients with another malignant disease.
Patients has participated in or participating in other clinical trials.
Patients with uncontrolled active infection.
Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
Patients with creatinine clearance rate < 50ml/min.
Patients with active hepatitis B or hepatitis C infection.
Patients with HIV infection.
Patients with active tuberculosis infection.
Patients with uncontrolled active bleeding.
Patients with a history of allergy to experimental drugs.
Patients with other commodities that the investigators considered not suitable for the enrollment.