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TKI Therapy Based on Molecular Monitoring in Allogeneic-HSCT Recipients With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

NCT01883219 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-11-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(TKI) therapy based on molecular monitoring of BCR/ABL levels in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)undergoing allogeneic hematopoietic stem cell transplantation(allo-HSCT).

Conditions

  • Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
  • Stem Cell Transplantation
  • Minimal Residual Disease

Interventions

DRUG

TKIs

Imatinib was given at a dose of 400mg/d or 600mg/d, dasatinib at a dose of 100mg/d or 140mg/d, and nilotinib at a dose of 400mg twice daily. If the patients had T315I mutations, ponatinib will be given. If the BCR/ABL levels increased or did not decrease after one month's use of TKI, donor lymphocyte infusion will be given and the TKI drugs will be modulated. If the patients experienced hematologic relapse, they will withdraw from the study.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Guangxi Medical University

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Guangzhou General Hospital of Guangzhou Military Command

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-06-30
Completion
2017-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01883219 on ClinicalTrials.gov