Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Phase 1

Withdrawn

• Conditions: Relapsed AML; T(8;21); C-KIT Mutation
• Interventions: Drug: Dasatinib

• Registration Number: NCT03560908
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Study Start: 2018-07-01
• Status Verified: 2020-03
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. T(8;21)acute myeloid leukemia patients with KIT D816 mutation diagnosed by bone marrow morphology, immunology, molecular genetics. The diagnosis and classification are according to WHO 2016 criteria.
2. Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
3. Age is not limited. Both male and female are eligible.
4. Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
5. Informed consent form must be signed by patients themselves before enrolled for patients aged 18 years or older. Informed consent form must be signed by the legal guardian for patients younger than 18 years.

Exclusion Criteria

1. Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
2. Isolated extramedullary relapsed leukemia.
3. With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasatinib plus chemotherapy	Dasatinib	Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation

Primary Outcome Measures

Name	Time	Method
composite complete remission (CR) rate	8 weeks	confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)

Secondary Outcome Measures

Name	Time	Method
mortality during induction chemotherapy	30 days	all deaths from start of chemotherapy
post relapsed overall survival	2 years	2 years overall survival from the date of relapse
overall survival	5 years	5 years overall survival from the date of diagnosis
post relapsed disease free survival	2 years	2 years disease free survival from the date of new complete remission

Trial Locations

Locations (1)

HBDH; 🇨🇳 Tianjin, Tianjin, China