CI

At a glance

ClinicalIndex Comparison Record
Phase 1Withdrawn· 0 enrolled
Drug / intervention
Dasatinibdrug
Likely dose
Dasatinib 70mgfrom 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/NCT03560908
NCT03560908Phase 1Withdrawn
Withdrawn
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Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Jun 18, 2018·Updated May 1, 2025

In Brief

A Phase 1 clinical trial evaluating Dasatinib for Relapsed AML and 2 related conditions. Withdrawn before enrollment, across 1 site.

Signals

Trial was withdrawn before enrollment

Detailed Summary

In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed AML, T(8;21), C-KIT Mutation
CountriesChina
Collaborators--

Timeline

Phase 1WithdrawnFinished
20192020202120222023202420252026
First PostedJun 18, 2018
Enrollment StartJul 1, 2018
Primary CompletionDec 31, 2020
Study CompletionDec 31, 2021
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 8.0 years ago

Interventions

Dasatinibdrug

Dasatinib 70mg twice a day will be administered orally for 2 weeks along with re-induction chemotherapy from day 1 of chemotherapy. Recommended re-induction regimens include (1)FLAG: Fludarabine 30mg/m2/d,d1-5;cytarabine 1g-2g/m2/d,d1-5;±G-CSF;(2)IA/DA:idarubicin 8-12mg/m2/d,d1-3 or daunorubicin 45-60mg/m2/d，d1-3;cytarabine 100-200mg/m2/d，d1-7;(3)CAG:Aclarubicin 20mg/d,d1-4；cytarabine 15mg/m2/Q12h,d1-14; ±G-CSF.The chemotherapy regimen is not limited to recommended regimens. Patients will be recommended to receive allogeneic hematopoietic stem cell transplantation (HSCT) once complete remission is achieved. Otherwise, they will continue the consolidation chemotherapy.