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

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ClinicalTrials.gov Identifier: NCT03560908
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
wang, jianxiang, Institute of Hematology & Blood Diseases Hospital

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.

Condition or disease Intervention/treatment Phase
Relapsed AML T(8;21) C-KIT Mutation Drug: Dasatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: Dasatinib plus chemotherapy
Dasatinib combined with chemotherapy for relapsed t(8;21) AML with D816 mutation
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.




Primary Outcome Measures :
  1. composite complete remission (CR) rate [ Time Frame: 8 weeks ]
    confirmed rate of complete remission (CR) plus complete remission with incomplete blood count(CRi)


Secondary Outcome Measures :
  1. mortality during induction chemotherapy [ Time Frame: 30 days ]
    all deaths from start of chemotherapy

  2. post relapsed overall survival [ Time Frame: 2 years ]
    2 years overall survival from the date of relapse

  3. overall survival [ Time Frame: 5 years ]
    5 years overall survival from the date of diagnosis

  4. post relapsed disease free survival [ Time Frame: 2 years ]
    2 years disease free survival from the date of new complete remission



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560908


Contacts
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Contact: Lijun Liu 86-22-23909237 bloodgcp@126.com
Contact: Jianxiang Wang, Dr. 86-22-23909120 wangjx@ihcams.ac.cn

Locations
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China, Tianjin
HBDH Recruiting
Tianjin, Tianjin, China, 300020
Contact: Hui Wei         
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Jianxiang Wang, Dr. Institute of Hematology & Blood Diseases Hospital

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Responsible Party: wang, jianxiang, Vice President of Institute, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT03560908     History of Changes
Other Study ID Numbers: IHBDH-IIT2018004
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by wang, jianxiang, Institute of Hematology & Blood Diseases Hospital:
leukemia,myeloid, acute
relapse
mutation
KIT
dasatinib

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action