PHII-PHD trial

JRCT ID: jRCTs031180284

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Philadelphia chromosome positive acute lymphoblastic leukemia
• Date of first enrollment: 25/10/2016
• Target sample size: 46
• Study type: Interventional
• Intervention(s): Multi-drug chemotherapy combined with Dasatinib and hematopoietic stem cell transplantation

Outcome(s)

• Primary Outcome: overall response
• Secondary Outcome: 2-year disease-free survival, event-free survival, overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1. Patient with Philadelphia chromosome-positive acute lymphoblastic leukemia, or blastic phase of chronic myelogenous leukemia who have not been diagnosed as chronic phase, or Philadelphia chromosome-positive mixed phenotype acute leukemia.
2. In case of Philadelphia chromosome negative, those who are BCR/ABL fusion gene positive.
3. over 18 years old and up to 65 years old
4. No prior treatment of anticancer drug, excluding pre-phase PSL.
5. ECOG performance status within 1 to 3
6. Appropriate organ function (heart, liver, kidney, lung) withstand dasatinib therapy.
7. Given after appropriate information, all participant provided written informed consent.

Exclude criteria

1.Patient with active double cancer
2.Patient with severe past illness, or uncontrollable complication
3. Prior TKI use or chemotherapy
4.HIV positive
5.HBs-Ag positive
6.Sever psychosis
7.Not to be eligible to study participation by attending physician

Related Information

• Primary Sponsor: Kanda Yoshinobu
• Secondary ID(s): UMIN000019313