Philadelphia chromosome-positive acute lymphoblastic leukemia Ph+ALL
Conditions
Interventions
1.The initial dose of dasatinib will be 40 mg q.d. Subsequently, MRD will be determined every 2 months, and administration will be continued at the same dose if MRD is negative and the dose will be in
Sponsors
Onizuka Makoto
Kataoka Keisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1). Eligibility criteria for enrollment of patients 1.Patients aged 16 years or older and 70 years or younger at the time of informed consent 2.Patients who have been diagnosed as having Ph+ALL and are expecting allogeneic hematopoietic stem cell transplantation 3.Patients whose MRD has been determined immediately before pretransplantation treatment 4.Patients who have given their own informed consent to participate in the study. 2). Eligibility criteria for starting administration of dasatinib 1.Acute GVHD at initiation of dasatinib administration is lower than Grade II 2.No lung disorder present in chronic GVHD at initiation of dasatinib administration 3.The platelet count is 100,000/ul or higher at initiation of dasatinib administration. 4.ECOG performance status of less than 2. 5.Functions of the primary organs are maintained. 6.No pleural effusion observed. 7.The patient's own informed consent to participate in the study has been obtained in writing, and the intention of withdrawal has not been expressed thereafter.
Exclusion criteria
Exclusion criteria: 1.Ph+ALL patients with T315I 2.Patients who have increased or added immunosuppressants because of exacerbation of GVHD within 2 weeks before initiation of dasatinib administration 3.Patients who are negative for pretransplantation MRD and remain negative even after transplantation 4.Patients in whom infiltration of leukemia cells into the central nervous system cannot be controlled 5.Patients with poorly-controlled diabetes mellitus in spite of continuous use of insulin 6.Patients with poorly-controlled hypertension in spite of the use of antihypertensive drugs 7.Patients with uncontrollable infection 8.Patients with sinusoidal obstruction syndrome (SOS) 9.Patients with uncontrollable thrombotic microangiopathy (TMA) 10.Patients with active double cancer 11.Patients with psychiatric symptoms 12.Other patients who are deemed to be ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Survival rate at 2 years after transplantation 2. Recurrence rate by 2 years after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events 2. Continuous administration period 3. Determination of minimal residual disease (MRD) after administration of dasatinib 4. BCR-ABL mutation analysis in recurrent cases | — |
Countries
Japan, mone
Contacts
Public ContactMakoto Onizuka
Tokai University Hospital
Outcome results
None listed