Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061529) titled 'A retrospective survey of FLEND therapy for relapsed or refractory T-cell acute lymphoblastic leukemia' on May 12.

Study Type: Observational

Primary Sponsor: Institute - Hamamatsu University School of Medicine

Condition: Condition - Relapsed and refractory T-cell acute lymphoblastic leukemia Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to retrospectively investigate the re-induction complete remission rate and adverse events of FLEND therapy (a combination chemotherapy of fludarabine, etoposide, and nelarabine) in pediatric and AYA patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL), and thereby to evaluate the efficacy and safety of this regimen. Since no standard re-induction regimen for relapsed or refractory T-ALL has yet been established in Japan, the findings will provide useful information to support the appropriate use of FLEND therapy in this population. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - 25 years-old >= Gender - Male and Female Key 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. Key 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. Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 05 Day Date of IRB - 2026 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 05 Month 12 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070407

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