CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 80 target
Drug / intervention
TKIsdrug
Likely dose
TKIs 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01883219
NCT01883219Phase 2Unknown
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Tyrosine Kinase Inhibitor Therapy Based on Molecular Monitoring of BCR/ABL Transcript Levels in Allogeneic Hematopoietic Stem Cell Transplant Recipients With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Nanfang Hospital, Southern Medical University·interventional·Posted Jun 21, 2013·Updated Nov 8, 2017

In Brief

A Phase 2 clinical trial evaluating TKIs for Philadelphia Chromosome Positive Acute Lymphocytic Leukemia and 2 related conditions. Targeting 80 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhiladelphia Chromosome Positive Acute Lymphocytic Leukemia, Stem Cell Transplantation, Minimal Residual Disease
CountriesChina
CollaboratorsPeking University People's Hospital, Guangxi Medical University, Guangdong Provincial People's Hospital, Guangzhou General Hospital of Guangzhou Military Command, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University

Timeline

Phase 2UnknownOverdue
2014201520162017201820192020202120222023202420252026
First PostedJun 21, 2013
Enrollment StartJun 1, 2013
Primary CompletionJun 1, 2016
Study CompletionNov 1, 2017
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 13.0 years ago

Interventions

TKIsdrug

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.