Phase II study of dasatinib and ponatinib switched by molecular response in newly diagnosed BCR-ABL1-positive acute lymphoblastic leukemia

Phase 2

• Conditions: B-lymphoblastic leukemia/lymphoma with t(9; 22)(q34; q11.2):BCR-ABL1; Philadelphia chromosome positive acute lymphoblastic leukemia, BCR-ABL1, dasatinib, ponatinib, HSCT; D054198

• Registration Number: JPRN-jRCTs041190096
• Lead Sponsor: Dobashi Nobuaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-13
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1) Patients diagnosed with B-lymphoblastic leukemia / lymphoma with BCR-ABL1 (B-lymphoblastic leukemia / lymphoma with t (9; 22) (q34; q11.2): BCR-ABL1 in WHO classification revision 4th edition (2017)
2) BCR-ABL1 fusion gene positive.
(1) The BCR-ABL1 fusion gene is positive by chimeric gene screening.
(2) If the above 1) and 2) (1) are satisfied, the patient is diagnosed with Ph + ALL unless there is a clear record suggesting the existence of chronic phase. This is a rule that even if the major BCR-ABL1 fusion gene positive patient is BCR-ABL positive in neutrophil FISH, this test does not diagnose it as the first acute conversion case of chronic myelogenous leukemia.
3) Patients older than 15 and more and under 65 at the time of consent acquisition.
4) There is no prior treatment with this antineoplastic drug for this disease. If the administration period of prednisolone is less than one week before confirming that the BCR-ABL1 fusion gene is positive, it is not regarded as a prior treatment history. An intrathecal injection of methotrexate 12 mg/body within 1 week from the start date of prednisolone administration is not also considered to be a prior treatment history.
5) ECOG PS of 0, 1, 2, or 3.
6) Patients must have adequate cardiac, hepatic, renal, and pulmonary functions.
(1) No serious abnormalities of QTc prolongation (481 msec or more, equivalent to grade 2 or more) in the electrocardiogram.
(2) In cases echocardiography example, no LVEF less than 50% serious abnormalities are observed.
(3) The serum bilirubin level is 2.0 mg / dL or less.
(4) Serum creatinine level is 2.0 mg / dL or less.
(5) Percutaneous oxygen saturation concentration is 94% or more in room air.
7) Voluntary written consent must be given before enrollment.
8) The diagnosis has been notified to the patient.

Exclusion Criteria

1. Heart disease
(1) Uncontrolled angina, heart failure, myocardial infarction
(2) Congenital long QT syndrome
(3) Ventricular arrhythmia
2. Pulmonary fibrosis, interstitial pneumonia
3. Uncontrolled diabetes
4. Infection (Grade 4)
5. HIV (+)
6. HBsAg (+)
7. Complications increasing the frequency of adverse events of dasatinib
8. Complications increasing the frequency of adverse events of ponatinib
9. Obvious bleeding tendency
10. Mental disorders
11. Active double cancer
12. Pregnant and lactating woman
13. The principal investigator or co-investigator decision

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year event-free survival rate

Secondary Outcome Measures

Name	Time	Method
# Adverse event rate, serious adverse event rate, <br># Complete hematological remission rate<br># Molecular response<br># complete molecular response rate<br># 3-year overall survival rate<br># 3-year relapse-free survival rate<br># Molecular response, complete molecular response rate, 3-year overall survival rate, 3-year event-free survival rate and 3-year relapse-free survival rate in cases treated with ponatinib