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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021286
Receipt No. 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 2020/03/06

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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
Email 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
Email osumi-t@ncchd.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

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
Email

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 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 No longer recruiting
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
2020 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024554

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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