Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia

Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia - Prospective observational study of relapse and refractory pediatric ALL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019878

Enrollment

Registered

2015-12-01

Start date

2015-12-01

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

acute lymphoblastic leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.relapsed or refractory ALL 2.Age<18y at diagnosis and <25y at relapse. 3.Patients who have been registered in the JPLSG CHM-14 study. 4.Informed consent is necessary. 5.Not included in other JPLSG studies.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
2 year EFS in all cases, in subgroups according to risk classification in 1st relapse cases, or numbers of relapse. Odd ratio in reinduction rate between clofarabine regimens and other regimens. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate.	—

Secondary

Measure	Time frame
2 year OS in all cases, or in subgroups according to risk classification in 1st relapse cases or numbers of relapse. 2nd progression free survival rate. Reinduction rate. Odds ratio in EFS between clofarabine regimens and other regimens. Odds ratio in OS between clofarabine regimens and other regimens. OS according to regimens or drugs used in reinduction therapy. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate in patients treated by clofarabine.	—

Measure

Time frame

2 year OS in all cases, or in subgroups according to risk classification in 1st relapse cases or numbers of relapse. 2nd progression free survival rate. Reinduction rate. Odds ratio in EFS between clofarabine regimens and other regimens. Odds ratio in OS between clofarabine regimens and other regimens. OS according to regimens or drugs used in reinduction therapy. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate in patients treated by clofarabine.

—

Countries

Japan

Contacts

Public ContactHiroaki Goto

Kanagawa Children's Medical Center Division of Hematology/Oncology

hgotou@kcmc.jp0457112351

Outcome results