UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023815 |
|---|---|
| Receipt number | 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 | 2021/03/31 10:53:28 |
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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
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
ctd-bzm@c-ctd.co.jp
Sponsor or person
Institute
Department of Pediatric Oncology, National Cancer Center Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027309
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