Phase II study for patient with Philadelphia chromosome positive acute lymphoblastic leukemia to determin the role of Dasatinb combined chemotherapy and allogeneic stem cell transplantation (PHII PHD)

Phase II study for patient with Philadelphia chromosome positive acute lymphoblastic leukemia to determin the role of Dasatinb combined chemotherapy and allogeneic stem cell transplantation (PHII PHD) - Phase II study for patient with Ph+ALL to determin the role of Dasatinb combined chemotherapy and allogeneic SCT (PH-II PH-D)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019313

Enrollment

Registered

2015-10-13

Start date

2015-10-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia

Interventions

1. PSL pre phase therapy: PSL 60mg/m2x7days 2. Induction chemotherapy: Dasatinib 140mg/body x 6 weeks + PSL 60mg/m2x2 weeks. At week 3 and 6, intrathecal MTX 15mg+Ara-C 40mg+DEX 4mg. 3. Conso

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Philadelphia chromosome positive, acute lymphoblastic leukemia, or blastic phase chronic myelogenous leukemia who are not comfirmed chronic phase, or mixed phenotype acute leukemia. 2.BCR/ABL chimera mRNA positive if patients are Ph negative. 3.Aged older than 18 years and under 65 years 4.Previously untreated except PSL in the prephase therapy 5.ECOG performance status of 0, 1, 2, 3 except 4 6.Patients must have normal cardiac, heaptic, renal, respiratory functions to tolerate dasatinib. (1)within normal range of ECG, ejection fruction (2)serum bililubin level of <2.0mg/dl (3)serum createnin level of <2.0mg/dl (4)saturation pulse O2 level over 94% under room air condition 7.Voluntary written informed consent must be given before enrollment. If patient are younger than 20, parental agreement must be included.

Exclusion criteria

Exclusion criteria: 1.Active another malignancy 2.Uncontrolled past disease or complication 3.Previously treated with tyrosine kinase inhibitor or cytotoxic chemotherapy. 4.HIV antibody positive patients 5.HBs-Antigen positive patients 6.Sever psychiatric illness 7.Another patients whose investigator decided inappropriate for entry into this study.

Design outcomes

Primary

Measure	Time frame
the rate of complete remission after induction chemotherapy	—

Secondary

Measure	Time frame
2 years disease free survival, event free survival, and over all survival	—

Countries

Japan

Contacts

Public ContactIekuni Oh

Jichi Medical University Department of hematology, division of internal medicine,

norma@jichi.ac.jp0285-58-7353

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026