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

C-KIT Mutation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03560908
• Other study ID #: IHBDH-IIT2018004
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• C-KIT Mutation
• Leukemia
• Leukemia, Myeloid, Acute
• Relapsed AML
• T(8;21)

Intervention

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.

Locations

Country	Name	City	State
China	HBDH	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite complete remission (CR) rate	confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)	8 weeks
Secondary	mortality during induction chemotherapy	all deaths from start of chemotherapy	30 days
Secondary	post relapsed overall survival	2 years overall survival from the date of relapse	2 years
Secondary	overall survival	5 years overall survival from the date of diagnosis	5 years
Secondary	post relapsed disease free survival	2 years disease free survival from the date of new complete remission	2 years