UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061968 |
|---|---|
| Receipt number | R000070912 |
| Scientific Title | Clinicopathological features and outcomes of hematopoietic stem cell transplantation for monomorphic epitheliotropic intestinal T-cell lymphoma: a systematic review |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/18 23:19:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinicopathological features and outcomes of hematopoietic stem cell transplantation for monomorphic epitheliotropic intestinal T-cell lymphoma: a systematic review
Acronym
Clinicopathological features and outcomes of hematopoietic stem cell transplantation for monomorphic epitheliotropic intestinal T-cell lymphoma: a systematic review
Scientific Title
Clinicopathological features and outcomes of hematopoietic stem cell transplantation for monomorphic epitheliotropic intestinal T-cell lymphoma: a systematic review
Scientific Title:Acronym
MEITL-HSCT-SR
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To systematically clarify the clinicopathological features and outcomes of autologous and allogeneic hematopoietic stem cell transplantation in monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)/type II enteropathy-associated T-cell lymphoma, with particular attention to reassessing published cases and studies for compatibility with contemporary diagnostic criteria for MEITL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Descriptive synthesis of post-transplant outcomes, including overall survival, relapse, and non-relapse mortality
Key secondary outcomes
1. Clinicopathological characteristics at diagnosis and at transplantation
2. Disease status before transplantation (CR/PR/SD/PD or non-CR)
3. Clinical context, indications, and treatment course of autologous and allogeneic transplantation
4. Incidence of acute and chronic graft-versus-host disease
5. Pathology-informed reassessment according to contemporary MEITL diagnostic criteria (definite / probable / atypical / uncertain)
Base
Study type
Others,meta-analysis etc
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Studies or case reports involving MEITL, type II enteropathy-associated T-cell lymphoma (type II EATL), or intestinal T-cell lymphomas considered compatible with these entities.
2. Reports describing autologous or allogeneic hematopoietic stem cell transplantation.
3. Case reports, case series, retrospective studies, and prospective studies will be eligible.
4. If a study includes other diseases, only reports in which data specific to MEITL/type II EATL can be extracted will be included.
5. No restrictions will be applied with respect to race, country of origin, publication date, or language.
Key exclusion criteria
1. Duplicate publications
2. Conference abstracts only
3. Reports exclusively involving classical EATL/type I EATL
4. Reports with insufficient pathological or clinical information to support compatibility with contemporary MEITL
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Jichi Medical University Hospital
Division name
Division of Hematlogy
Zip code
329-0431
Address
3311-1, Yakushiji, Shimotuke, Tochigi, Japan
TEL
0285-58-7353
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryutaro |
| Middle name | |
| Last name | Tominaga |
Organization
Jichi Medical University Hospital
Division name
Division of Hematology
Zip code
329-0431
Address
3311-1, Yakushiji, Shimotuke, Tochigi, Japan
TEL
0285-58-7353
Homepage URL
rtominaga-tky@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
None
Address
None
Tel
None
None
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 | 06 | Month | 23 | 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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 25 | 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
A systematic search will be conducted using PubMed and Embase. Search terms will include "monomorphic epitheliotropic intestinal T-cell lymphoma," "MEITL," "type II enteropathy-associated T-cell lymphoma," "type II EATL," and "enteropathy-associated T-cell lymphoma type II," as well as related terms such as "intestinal T-cell lymphoma" to avoid omissions due to historical classifications or ambiguous descriptions.
Two investigators will independently screen studies according to the predefined selection criteria to determine eligibility. Discrepancies in screening decisions will be resolved through discussion between the two investigators; if consensus cannot be reached, a third investigator will adjudicate.
At the case or study level, extract data on age, sex, race/ethnicity, diagnostic label, year of diagnosis, stage at diagnosis, primary site, pre-transplant treatment, disease status at transplant, transplant type (autologous/allogeneic), donor, conditioning regimen, GVHD, recurrence, non-recurrence-related death, and survival outcomes.
Furthermore, we will extract pathological features such as morphology (monomorphic, epitheliotropism), immunophenotype (CD3, CD4, CD8, CD56, CD30, EBER, TIA-1, granzyme B, etc.), and celiac disease-related findings, and classify their consistency with the current MEITL into definite, probable, atypical, or uncertain.
Because of substantial heterogeneity in diagnostic criteria, transplant indications, outcome definitions, and time-zero definitions (diagnosis vs transplantation), a quantitative meta-analysis will not be performed in principle. Instead, findings will be synthesized, separately summarizing the background, pathology-informed diagnostic compatibility, transplant context, and outcomes of autologous and allogeneic transplantation.
Management information
Registered date
| 2026 | Year | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070912
