NCT04446130

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

June 22, 2020

Last Update Submit

June 22, 2020

Conditions

Induction ChemotherapyAcute T-Lymphocytic LeukemiaT-cell Lymphoblastic Lymphoma LeukemiaT-cell/Myeloid Mixed Phenotype Acute Leukemia

Keywords

T-ALL/LBLT/M-MPALDecitabine combined with HAAG

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 28-35 of induction course

Secondary Outcomes (4)

  • Overall survival (OS)

    4 years

  • Leukemia-free survival (LFS)

    4 years

  • Cumulative incidence of relapse(CIR)

    4 years

  • Number of adverse events

    3 years

Study Arms (1)

Decitabine combined with HAAG Regimen

EXPERIMENTAL

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

Interventions

Decitabine combined with HAAG RegimenDRUG

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

Decitabine combined with HAAG Regimen

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Xiaowen Tang, Ph.D.

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Tang, Ph.D.

CONTACT

(0086)51267781856xwtang1020@163.com

Depei Wu, Ph.D.

CONTACT

(0086)51267781856drwudepei@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

CN(1)