UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021286 |
|---|---|
| Receipt number | R000024554 |
| Scientific Title | Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients (JPLSG B-NHL-14) |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2024/03/08 09:10:31 |
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Basic information
Public title
Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients (JPLSG B-NHL-14)
Acronym
JPLSG B-NHL-14
Scientific Title
Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients (JPLSG B-NHL-14)
Scientific Title:Acronym
JPLSG B-NHL-14
Region
| Japan |
Condition
Condition
B-cell NHL or Mature B-cell Acute Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For the patients with advanced stage B-cell NHL/B-AL to evaluate efficacy and safety of rituximab added to standard LMB chemotherapy regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event free survival
Key secondary outcomes
- Survival
- Complete remission rate
- Acute and long term toxicity
- Immune reconstitution assessed by immunogloburin level and lymphocyte counts
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients will receive a total of 6 injections of the antibody: 2 at 48h interval at D-2 and D1 of the 2 COPADM courses and one injection at D1 of the 2 consolidation courses either CYM (B) or CYVE (C1 or C3). Rituximab is given at the dose of 375 mg/m2 I.V.
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
| 6 | months-old | <= |
Age-upper limit
| 216 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Histology and staging disease
- Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
- Stage III with elevated LDH level, (LDH > twice the institutional upper limit of the adult normal values) or any stage IV or B-AL.
Key exclusion criteria
Histology and staging disease
- Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study - In phase II study (PMLBL) patients with CNS involvement are not eligible.
General conditions
- Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ
transplantation, previous malignancy of any type, or known positive HIV serology.
- Evidence of pregnancy or lactation period.
- There will be no exclusion criteria based on organ function. Dosing guidelines for organ
dysfunction are provided in annexe D1.
Prior therapy
Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total.
Exclusion criteria related to rituximab
- Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria).
- Prior exposure to rituximab.
- Severe active viral infection, especially hepatitis B.
- Severe infection (such as sepsis, pneumonia,
etc.) should be clinically controlled at the time of registration. Contact the national co-
investigator for further advice if necessary.
- Hepatitis B carrier status history of HBV or positive serology. A patient is considered as HBV
carrier or to have (had) HBV infection in case of:
- Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive,
- Immunized and HBsAG and/or anti-HBc antibody positive.
Others
- Participation in another investigational drug clinical trial.
- Patients who, for any reason, are not able to comply with the national legislation.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mori |
Organization
St. Marianna University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
morite@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Osumi |
Organization
National Center for Child Health and Development
Division name
Division of Leukemia and Lymphoma, Children's Cancer Center
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
03-3416-0181
Homepage URL
osumi-t@ncchd.go.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
Funding Source
Organization
Grant for clinical cancer research from the Japan Agency for Medical Research and Development, Japan
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
Address
Tel
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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024554
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| Registered date | File name |
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| Registered date | File name |
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