UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060328 |
|---|---|
| Receipt number | R000069006 |
| Scientific Title | Efficacy of autologous and allogeneic hematopoietic cell transplantation in adults with extranodal NK/T-cell lymphoma: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2026/01/11 |
| Last modified on | 2026/01/11 16:23:51 |
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Basic information
Public title
Efficacy of autologous and allogeneic hematopoietic cell transplantation in adults with extranodal NK/T-cell lymphoma: a systematic review and meta-analysis
Acronym
Efficacy of autologous and allogeneic hematopoietic cell transplantation in adults with extranodal NK/T-cell lymphoma: a systematic review and meta-analysis
Scientific Title
Efficacy of autologous and allogeneic hematopoietic cell transplantation in adults with extranodal NK/T-cell lymphoma: a systematic review and meta-analysis
Scientific Title:Acronym
Efficacy of autologous and allogeneic hematopoietic cell transplantation in adults with extranodal NK/T-cell lymphoma: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
extranodal NK/T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of autologous and allogeneic hematopoietic stem cell transplantation for adult extranodal NK/T-cell lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival, disease free survival, relapse free survival, rate of non-relapse mortality, relapse rate, rate of acute and chronic graft-versus-host disease
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adult patients with extranodal NK/T-cell lymphoma (ENKL).
2. Patients who underwent treatment with autologous or allogeneic hematopoietic stem cell transplantation.
Study design:
A comprehensive literature search will be conducted in PubMed and Embase according to the search strategy described below (see the "Other" section). No restrictions will be applied with respect to language, country of origin, publication date, study design (prospective or retrospective), single-center or multicenter setting, or registry-based studies. Eligible studies must include at least five patients with ENKL. If a study includes patients with other diseases, only data specific to ENKL patients will be extracted and analyzed.
Key exclusion criteria
1.Duplicate publications
2.Conference proceedings
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 Hematology
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
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 01 | Month | 11 | 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 | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data sources and search strategy
Using the search strategy described below, a systematic review (SR) will be conducted in PubMed and Embase on January 11, 2026.
PubMed:
( "Lymphoma, Extranodal NK-T-Cell"[Mesh] OR "NK/T-cell lymphoma"[tiab] OR "NK T cell lymphoma"[tiab] OR "natural killer/T-cell lymphoma"[tiab] OR "natural killer cell lymphoma"[tiab] OR "nasal NK/T-cell lymphoma"[tiab] OR "ENKTL"[tiab] OR "ENKL"[tiab])
AND
( "Hematopoietic Stem Cell Transplantation"[Mesh] OR "hematopoietic cell transplantation"[tiab] OR "stem cell transplant*"[tiab] OR "HSCT"[tiab] OR "bone marrow transplant*"[tiab] OR "peripheral blood stem cell transplant*"[tiab] )
Embase:
( TI,AB("NK/T-cell lymphoma") OR TI,AB("NK T cell lymphoma") OR TI,AB("natural killer/T-cell lymphoma") OR TI,AB("natural killer cell lymphoma") OR TI,AB("nasal NK/T-cell lymphoma") OR TI,AB(ENKL) OR TI,AB(ENKTL))
AND
( TI,AB("hematopoietic stem cell transplantation") OR TI,AB("hematopoietic cell transplantation") OR TI,AB("stem cell transplantation") OR TI,AB("stem cell transplant*") OR TI,AB(HSCT) OR TI,AB("bone marrow transplantation") OR TI,AB("peripheral blood stem cell transplantation"))
Study selection and statistical analysis
Two investigators will independently screen studies according to predefined eligibility criteria. Disagreements will be resolved by discussion or consultation with a third investigator. Study quality will be assessed using the modified Newcastle-Ottawa Scale for single-arm studies.
For the meta-analysis (MA), raw proportions will be pooled using a random-effects model in studies with comparable designs and outcomes. Analyses will be performed using EZR (Saitama Medical Center, Jichi Medical University, Japan). Heterogeneity will be assessed using the I2 statistic, with I2 >30 percent indicating moderate and >60 percent high heterogeneity.
Management information
Registered date
| 2026 | Year | 01 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069006
