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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

Primary Purpose

Induction Chemotherapy, Acute T-Lymphocytic Leukemia, T-cell Lymphoblastic Lymphoma Leukemia

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Decitabine combined with HAAG Regimen
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction Chemotherapy focused on measuring T-ALL/LBL, T/M-MPAL, Decitabine combined with HAAG

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decitabine combined with HAAG Regimen

Arm 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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
June 22, 2020
Last Updated
June 22, 2020
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Henan Cancer Hospital, Shandong Provincial Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changzhou No.2 People's Hospital, The Second People's Hospital of Huai'an
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1. Study Identification

Unique Protocol Identification Number
NCT04446130
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
Henan Cancer Hospital, Shandong Provincial Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changzhou No.2 People's Hospital, The Second People's Hospital of Huai'an

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decitabine combined with HAAG Regimen
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Decitabine combined with HAAG Regimen
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
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.
Time Frame
Day 28-35 of induction course
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
time from randomization to death from any cause
Time Frame
4 years
Title
Leukemia-free survival (LFS)
Description
time from randomization to the first relapse or death
Time Frame
4 years
Title
Cumulative incidence of relapse(CIR)
Description
time from achievement of a remmission to the first relapse
Time Frame
4 years
Title
Number of adverse events
Description
adverse events are evaluated with CTCAE V5.0.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, Ph.D.
Phone
(0086)51267781856
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Depei Wu, Ph.D.
Phone
(0086)51267781856
Email
drwudepei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, Ph.D
Phone
(0086)51267781856
Email
xwtang1020@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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