KSGCT1601(DASALL II)

Phase 2

• Conditions: Ph+A; Philadelphia chromosome-positive acute lymphoblastic leukemia; Ph+ALL

• Registration Number: JPRN-jRCTs031180213
• Lead Sponsor: Onizuka Makoto

Brief Summary

The survival rate at 2 years after transplantation, the primary endpoint, was 100%, and the recurrence rate up to 2 years after transplantation was 6%. It should be noted that the required number of cases for the primary endpoint analysis has not been reached, so it is considered difficult to publish this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-08
• Study Completion: 2022-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 17

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Survival rate at 2 years after transplantation <br>2. Recurrence rate by 2 years after transplantation

Secondary Outcome Measures

Name	Time	Method
1. Adverse events <br>2. Continuous administration period <br>3. Determination of minimal residual disease (MRD) after administration of dasatinib <br>4. BCR-ABL mutation analysis in recurrent cases