UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061529 |
|---|---|
| Receipt number | R000070407 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/05/12 |
| Last modified on | 2026/05/11 21:43:20 |
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Basic information
Public title
A retrospective survey of FLEND therapy for relapsed or refractory T-cell acute lymphoblastic leukemia
Acronym
Relapsed T-ALL FLEND Study (JPLSG-ALL-RT23)
Scientific Title
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
Scientific Title:Acronym
Relapsed T-ALL FLEND Study (JPLSG-ALL-RT23)
Region
| Japan |
Condition
Condition
Relapsed and refractory T-cell acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete remission rate after FLEND therapy among relapsed T-ALL patients who were not in remission at the start of FLEND therapy
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kimiyoshi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Pediatrics
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2312
k-saka@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kimiyoshi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Pediatrics
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2312
Homepage URL
k-saka@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
Tel
053-435-2680 / 053-435-2680
rinri@hama-med.ac.jp / rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:
A multi-institutional retrospective observational study, not an intervention
Study duration:
Research period: from the date of approval to December 31, 2027
Data collection period: from the date of approval to December 31, 2026
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070407
