A retrospective survey of FLEND therapy for relapsed or refractory T-cell acute lymphoblastic leukemia

A retrospective observational study on the efficacy and safety of FLEND therapy (combination of fludarabine, etoposide, and nelarabine) for relapsed and refractory T-cell acute lymphoblastic leukemia - Relapsed T-ALL FLEND Study (JPLSG-ALL-RT23)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061529

Enrollment

Registered

2026-05-12

Start date

2026-05-12

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

Relapsed and refractory T-cell acute lymphoblastic leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who fulfill all of the following criteria are eligible. 1) Age 25 years or younger at the time of induction failure or diagnosis of relapse. For patients with multiple relapses, only relapse episodes occurring at age 25 years or younger are included. 2) Diagnosed with T-ALL that relapsed or was refractory (induction failure) on or after January 1, 2013, or relapsed on or before December 2012 with the relapsed state persisting after 2013. For patients with multiple relapses, only relapse episodes occurring on or after January 1, 2013 are included. 3) Have a history of receiving FLEND therapy between January 1, 2013 and December 31, 2024. 4) The attending physician has consented to participate in this survey study.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria are excluded from this study. 1) Patients previously enrolled in the ALL-RT11 trial. 2) Patients from whom consent to participate in this survey study could not be obtained. 3) Patients judged inappropriate for participation in this study by the principal investigator or sub-investigators.

Design outcomes

Primary

Measure	Time frame
Complete remission rate after FLEND therapy among relapsed T-ALL patients who were not in remission at the start of FLEND therapy	—

Secondary

Measure	Time frame
1) CR rate of patients who were not in remission before FLEND therapy, stratified by disease stage 2) Minimal residual disease (MRD) after each cycle of FLEND therapy. 3) CR maintenance rate of patients who were in CR before FLEND therapy, stratified by disease stage. 4) Duration of CR maintenance of patients who were in CR before FLEND therapy, stratified by disease stage. 5) Incidence of adverse events associated with FLEND therapy, stratified by disease stage. 6) Proportion of patients undergoing hematopoietic stem cell transplantation after FLEND therapy. 7) 4-month and 1-year event-free survival (EFS) after FLEND therapy, stratified by disease stage. 8) 4-month and 1-year overall survival (OS) after FLEND therapy, stratified by disease stage.	—

Measure

Time frame

1) CR rate of patients who were not in remission before FLEND therapy, stratified by disease stage 2) Minimal residual disease (MRD) after each cycle of FLEND therapy. 3) CR maintenance rate of patients who were in CR before FLEND therapy, stratified by disease stage. 4) Duration of CR maintenance of patients who were in CR before FLEND therapy, stratified by disease stage. 5) Incidence of adverse events associated with FLEND therapy, stratified by disease stage. 6) Proportion of patients undergoing hematopoietic stem cell transplantation after FLEND therapy. 7) 4-month and 1-year event-free survival (EFS) after FLEND therapy, stratified by disease stage. 8) 4-month and 1-year overall survival (OS) after FLEND therapy, stratified by disease stage.

—

Countries

Japan

Contacts

Public ContactKimiyoshi Sakaguchi

Hamamatsu University School of Medicine Department of Pediatrics

k-saka@hama-med.ac.jp053-435-2312

Outcome results