Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)

Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study) - Autologous peripheral blood stem cell transplantation for Ph+ALL (Auto-Ph17 study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026445

Enrollment

Registered

2017-04-17

Start date

2017-06-13

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

Philadelphia chromosome-positive acute lymphoblastic leukemia

Interventions

Peripheral blood stem cell harvest is performed following JALSG Ph+ALL213 C2 regimen (CPM/DNR/VCR/PSL). Peripheral blood stem cell transplantation is performed using LEED regimen (L-PAM/CPM/ETP/DEX).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute lymphoblastic leukemia. 2. BCR/ABL positive. 3. aged >= 55 years and <= 70 years. 4. Newly diagnosed patients. 5. Complete molecular remission was achieved within 3 chemotherapy regimens. 6. ECOG performance status of 0, 1, 2 or 3. 7. Patients must have adequate cardiac, hepatic, renal, and pulmonary functions. 8. Voluntary written consent must be given before enrollment.

Exclusion criteria

Exclusion criteria: 1. Heart insufficiency. 2. Pulmonary fibrosis, interstitial pneumonitis. 3. Uncontrollable diabetes mellitus. 4. Grade 4 infection. 5. HIV antibody positive. 6. HBs antigen positive. 7. Acquired bleeding diathesis. 8. Psychiatric illness. 9. Active another malignancy. 10. Patients who, in the judgment of the investigator, would be inappropriate for entry into this study.

Design outcomes

Primary

Measure	Time frame
Day 100- mortality after transplantation	—

Secondary

Measure	Time frame
1) Day 100- molecular and hematological replase rate. 2) 1 year- molecular and hematological replase rate. 3) 3 year- molecular and hematological replase rate. 4) Day 100- overall survival, event-free survival, relapse rate and non-relapse mortality. 5) 1 year- overall survival, event-free survival, relapse rate and non-relapse mortality. 6) 3 year- overall survival, event-free survival, relapse rate and non-relapse mortality. 7) The proportion of therapy related mortality. 8) The proportion of adverse events in each regimen. 9) Success rate of peripheral blood stem cell harvest. 10) Detection of BCR-ABL chimeric gene in harvested peripheral blood stem cell by real-time quantitative PCR. 11) Safety of peripheral blood stem cell transplantation (the proportion of engraftment and engraftment failure). 12) Cumulative dose of dasatinib during maintenance therapy. 13) Mutation analysis of BCR-ABL chimeric gene in relapsed patients.	—

Measure

Time frame

1) Day 100- molecular and hematological replase rate. 2) 1 year- molecular and hematological replase rate. 3) 3 year- molecular and hematological replase rate. 4) Day 100- overall survival, event-free survival, relapse rate and non-relapse mortality. 5) 1 year- overall survival, event-free survival, relapse rate and non-relapse mortality. 6) 3 year- overall survival, event-free survival, relapse rate and non-relapse mortality. 7) The proportion of therapy related mortality. 8) The proportion of adverse events in each regimen. 9) Success rate of peripheral blood stem cell harvest. 10) Detection of BCR-ABL chimeric gene in harvested peripheral blood stem cell by real-time quantitative PCR. 11) Safety of peripheral blood stem cell transplantation (the proportion of engraftment and engraftment failure). 12) Cumulative dose of dasatinib during maintenance therapy. 13) Mutation analysis of BCR-ABL chimeric gene in relapsed patients.

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Countries

Japan

Contacts

Public ContactSatoshi Nishiwaki

Nagoya University Hospital Center for Advanced Medicine and Clinical Research

n-3104@med.nagoya-u.ac.jp052(744)-2942

Outcome results

None listed

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