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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023815
Receipt No. R000027309
Scientific Title A Phase II study of combination chemotherapy including Bortezomib in pediatric patients with relapsed acute lymphoblastic leukemia (Investigator-initiated clinical trial)
Date of disclosure of the study information 2016/09/09
Last modified on 2018/09/06

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Basic information
Public title A Phase II study of combination chemotherapy including Bortezomib in pediatric patients with relapsed acute lymphoblastic leukemia (Investigator-initiated clinical trial)
Acronym Bortezomib for relapsed ALL (BZM-ALL-2)
Scientific Title A Phase II study of combination chemotherapy including Bortezomib in pediatric patients with relapsed acute lymphoblastic leukemia (Investigator-initiated clinical trial)
Scientific Title:Acronym Bortezomib for relapsed ALL (BZM-ALL-2)
Region
Japan

Condition
Condition A high-risk group of pediatric patients with first relapse of ALLor refractory ALL (patients who develop 2nd or subsequent relapse, relapse after hematopoietic cell transplantation or fail to achieve remission induction with one or more therapies).
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of combination chemotherapy including Bortezomib (Investigational Ingredient Code: JNJ-26866138; Brand Name: Velcade; hereinafter referred to as "investigational product") (B-PVLDC-TIT) in a high-risk first relapse group of pediatric patients with acute lymphoblastic leukemia (ALL).
To evaluate the efficacy for refractory ALL in expansion cohort.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Remission induction rate at the end of remission induction therapy using B-PVLDC-TIT regimen
Key secondary outcomes 1) Minimal Residual Disease (MRD) at the end of remission induction therapy using B-PVLDC-TIT regimen
2) 4-month event-free survival, overall survival, MRD at 4-month , where events are defined as relapse and death.
3) Proportion of the patients in remission and MRD at the start of transplantation conditioning
4) Duration of remission
5) Profile of adverse events occurring up to Day 28 of combination chemotherapy period

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In addition to the standardized induction therapy, intravenous administration of Bortezomib will be given at a dose of 1.3mg/m2 on Days 1, 4, 8, and 11.
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
19 years-old >=
Gender Male and Female
Key inclusion criteria 1) Acute lymphoblastic leukemia (ALL), except mature B-cell ALL
2) First relapsed patients who are classified as high risk (S3 or S4) in the Risk Classification for First ALL Relapse
In expansion cohort, patients who develop 2nd or subsequent relapse, relapse after hematopoietic cell transplantation or fail to achieve remission induction with one or more therapies.
3) Patients who were 17 years or younger at the first onset and 19 years or younger at relapse.
In expansion cohort, patients who were 17 years or younger at the first onset and 19 years or younger at the time of informed consent.
4) ECOG Performance Status 0 to 2
5) The percentage of blast cells in the bone marrow is 5% or higher.
6) Patients who received the last chemotherapy for first-onset ALL 7 or more days before the day of enrollment, and who have not started treatment of relapsed ALL
In expansion cohort, patients who received the last chemotherapy for ALL 7 or more days before the day of enrollment.
7) Without following previous histories/complications:
Grade 2 or worse CNS or peripheral nerve disorder
Deep mycosis, interstitial pneumonia, pulmonary fibrosis
Hypersensitivity to mannitol, boron, or other components of the drugs in the trial regimen
8) Patients meeting the following requirements as indicated by laboratory tests within 14 days before enrollment:
1. SpO2 >=96% and chest CT indicating no abnormal finding in the lung fields
2. KL-6, SP-D, beta-D glucan, Candida antigen, and Aspergillosis antigen are within normal range
3. AST, ALT: <= 5x ULN
4. Serum bilirubin: <= 2.0mg/dL
5. Creatinine: <= 2x ULN
6. 12-lead ECG indicating no abnormality requiring treatment and/or no abnormal conducting system
9) Patients who can receive PSL monotherapy and combination therapy during hospitalization
10) Consent to participate in this study obtained from the subject's representative
Key exclusion criteria 1) Patients who received hematopoietic cell transplantation(only in high risk group of first relapse)
2) Patients who received allograft transplantation within 4 months(120 days) (only in expansion cohort)
3) Patients who received immunosuppressant within 14 days
4) Double cancer
5) Concurrent infection requiring systemic treatment at enrollment
6) Fever over 38.5 degrees Celsius
7) Pregnant or possibly pregnant women. Breastfeeding women. Men and women providing no consent to avoiding pregnancy during the study.
8) Determined as difficult to participate in the study because of complicated psychiatric disease or mental symptoms
9) The following complications or previous histories:
Previous cardiac disease
Patients with a history of continuous oxygen therapy required for treatment or a history of respiratory function impairment
Patients with complications determined to seriously compromise conducting of the study (for example, uncontrollable diabetes)
10) CNS disorder
11) Down syndrome
12) Patients determined as ineligible for participation in the study by an investigator or a sub-investigator for other reasons
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chitose Ogawa
Organization National Cancer Center Hospital
Division name Department of Pediatric Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Email ncch-bzm@c-ctd.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miwa Izutsu
Organization CTD Inc.
Division name -
Zip code
Address 3-3-2, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-6228-4878
Homepage URL
Email ctd-bzm@c-ctd.co.jp

Sponsor
Institute Department of Pediatric Oncology, National Cancer Center Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Janssen Pharmaceutical K.K.
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 国立がん研究センター中央病院(東京都)、神奈川県立こども医療センター(神奈川県)、 京都大学医学部附属病院(京都府)、福島県立医科大学附属病院(福島県)、名古屋医療センター(愛知県)、新潟県立がんセンター新潟病院(新潟県)、国立成育医療研究センター(東京都)、三重大学医学部附属病院(三重県)、兵庫県立こども病院(兵庫県)、大阪市立総合医療センター(大阪府)、広島大学病院(広島県)、九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 09 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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 21 Day
Last follow-up date
2020 Year 02 Month 29 Day
Date of closure to data entry
2020 Year 03 Month 15 Day
Date trial data considered complete
2020 Year 04 Month 30 Day
Date analysis concluded
2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027309

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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