Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia.

Phase II study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. - Study of multi-agent chemotherapy in patients with adult Philadelphia chromosome negative precursor B acute lymphoblastic leukemia. (JALSG Ph(-)B-ALL213)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010619

Enrollment

160

Registered

2013-05-15

Start date

2013-07-07

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 negative precursor B acute lymphoblastic leukemia

Interventions

Induction therapy, Consolidation therapy, Maintenance therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Recognized ALL 2. Precursor B-ALL (diagnosed by WHO Classification) 3. Age 15 to 64 4. Performance Status: 0 to 3 5. Adequate hepatic, renal and cardiac function 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previously treated with leukapheresis 2. Congestive heart failure 3. Recent history of myocardial infarction 4. Malignant hypertension 5. Lung fibrosis 6. Interstitial pneumonitis 7. Severe comorbidity (diabetes mellitus, infection or liver cirrhosis) 8. Positive anti-HIV antibody or HBs antigen 9. Thrombosis which need treatment 10. Psychological disorders 11. Other active neoplasms 12. Pregnant and/or lactating woman 13. Judged to be inadequate

Design outcomes

Primary

Measure	Time frame
3 year event free survival (EFS)	—

Secondary

Measure	Time frame
Complete remission rate Adverse event rate 3 year overall survival (OS), and relapse free survival (RFS) Efficacy and safety of hematopoietic stem cell transplantation such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), and chronic GVHD Relationship between initial steroid reactivity (Blast rates of bone marrow on Day 15) and prognosis such as OS, EFS and RFS	—

Measure

Time frame

Complete remission rate Adverse event rate 3 year overall survival (OS), and relapse free survival (RFS) Efficacy and safety of hematopoietic stem cell transplantation such as treatment related mortality, relapse, engraftment, acute graft versus host disease (GVHD), and chronic GVHD Relationship between initial steroid reactivity (Blast rates of bone marrow on Day 15) and prognosis such as OS, EFS and RFS

—

Countries

Japan

Contacts

Public ContactYoshihiro Hatta

JALSG-ALL213 research secretariat Hematology and Rheumatology, Nixon University School of Medicine

hatta.yoshihiro@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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