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

June 22, 2020 updated by: The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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.
Day 28-35 of induction course

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-HAAG-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Induction Chemotherapy

Clinical Trials on Decitabine combined with HAAG Regimen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe