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

Overview

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.

Full Title of Study: “Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Drug: Dasatinib
    • 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.

Arms, Groups and Cohorts

  • Experimental: Dasatinib plus chemotherapy
    • Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation

Clinical Trial Outcome Measures

Primary Measures

  • composite complete remission (CR) rate
    • Time Frame: 8 weeks
    • confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Hematology & Blood Diseases Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: wang, jianxiang, Vice President of Institute – Institute of Hematology & Blood Diseases Hospital
  • Overall Official(s)
    • Jianxiang Wang, Dr., Principal Investigator, Institute of Hematology & Blood Diseases Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.