Back to resultsDasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Primary Purpose
Relapsed AML, T(8;21), C-KIT Mutation
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed AML focused on measuring leukemia,myeloid, acute, relapse, mutation, KIT, dasatinib
Eligibility Criteria
Inclusion Criteria:
- 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.
- Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
- Age is not limited. Both male and female are eligible.
- Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
- 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:
- Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
- Isolated extramedullary relapsed leukemia.
- With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.
Sites / Locations
- HBDH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dasatinib plus chemotherapy
Arm Description
Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation
Outcomes
Primary Outcome Measures
composite complete remission (CR) rate
confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)
Secondary Outcome Measures
mortality during induction chemotherapy
all deaths from start of chemotherapy
post relapsed overall survival
2 years overall survival from the date of relapse
overall survival
5 years overall survival from the date of diagnosis
post relapsed disease free survival
2 years disease free survival from the date of new complete remission
Full Information
NCT ID
NCT03560908
First Posted
June 1, 2018
Last Updated
March 19, 2020
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT03560908
Brief Title
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Official Title
Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No enough eligable participants enrolled
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed AML, T(8;21), C-KIT Mutation
Keywords
leukemia,myeloid, acute, relapse, mutation, KIT, dasatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dasatinib plus chemotherapy
Arm Type
Experimental
Arm Description
Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
composite complete remission (CR) rate
Description
confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
mortality during induction chemotherapy
Description
all deaths from start of chemotherapy
Time Frame
30 days
Title
post relapsed overall survival
Description
2 years overall survival from the date of relapse
Time Frame
2 years
Title
overall survival
Description
5 years overall survival from the date of diagnosis
Time Frame
5 years
Title
post relapsed disease free survival
Description
2 years disease free survival from the date of new complete remission
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
Age is not limited. Both male and female are eligible.
Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
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:
Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
Isolated extramedullary relapsed leukemia.
With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxiang Wang, Dr.
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
HBDH
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
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