UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015980 |
|---|---|
| Receipt number | R000018581 |
| Scientific Title | A phase I study (investigator-initiated) on the safety and pharmacokinetics of Bortezomib with combination chemotherapy in pediatric and young adult patients with refractory acute lymphocytic leukemia |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2017/07/25 09:50:59 |
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Basic information
Public title
A phase I study (investigator-initiated) on the safety and pharmacokinetics of Bortezomib with combination chemotherapy in pediatric and young adult patients with refractory acute lymphocytic leukemia
Acronym
Bortezomib for relapsed ALL (BZM-ALL-1)
Scientific Title
A phase I study (investigator-initiated) on the safety and pharmacokinetics of Bortezomib with combination chemotherapy in pediatric and young adult patients with refractory acute lymphocytic leukemia
Scientific Title:Acronym
Bortezomib for relapsed ALL (BZM-ALL-1)
Region
| Japan |
Condition
Condition
Refractory acute lymphocytic leukemia(ALL) in children and young adults
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the tolerability and safety of Bortezomib with combination chemotherapy in pediatric and young adult patients with refractory ALL, and evaluate the pharmacokinetics of Bortezomib administered concurrently. To evaluate complete remission as well as minimal residual disease (MRD) after induction therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Dose-limiting toxicity (DLT)
Pharmacokinetics of Bortezomib
Key secondary outcomes
Complete remission(CR) after induction therapy
Minimal residual disease after induction therapy
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 1.3 or 1.0 mg/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
| 1 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 1-29 years old when obtaining consent.
2) Consent to participate in this study obtained from the subject or his/her representative.
3) Diagnosed with ALL
4) Patients meeting any one of the following requirements:
1. 1st bone marrow relapse within 36 months after the date of initial diagnosis of ALL
2. 2nd or subsequent bone marrow relapse
3. Bone marrow relapse after hematopoietic cell transplantation
4. Failure to achieve remission induction with one or more therapies
5) At least 7 days elapsed from the final dose of chemotherapy to the day of enrollment.
6) ECOG Performance Status 0 to 2
7) Patients meeting the following requirements as indicated by laboratory tests within 14 days before enrollment with sufficiently preserved liver, renal, and cardiac functions.
1. AST and ALT <= 5x ULN*
2. Serum bilirubin <= 2.0 mg/dL
3. Creatinine <= 2x ULN
4. 12-lead ECG indicating no abnormality requiring treatment and/or no abnormal conducting system.
8) SpO2 >= 96% and chest CT indicating no abnormal finding in the lung fields.
9) Patients who can receive PSL monotherapy and combination therapy during hospitalization.
* Child-specific normal limit for patients younger than 18 years old and site-specific normal limit for patients aged 18 years or older
Key exclusion criteria
1) Mature B-cell ALL (L3)
2) Previous treatment with Bortezomib
3) The following complications/previous histories:
1. Concurrent infection requiring systemic treatment at enrollment.
2. Previous cardiac disease: previous myocardial infarction/angina pectoris within 12 months before enrollment.
3. Patients requiring oxygenation or showing respiratory insufficiency.
4. Previous interstitial pneumonia or pulmonary fibrosis.
5. Abnormal pulmonary function test, KL-6, SP-D, and SP-A as demonstrated by screening tests.
6. Abnormal beta-D glucan, Candida antigen, and Aspergillosis antigen as demonstrated by screening tests.
7. Previous deep fungus infection.
8. CNS or peripheral disorder.
9. Other complications determined to seriously compromise conducting of the study (for example, uncontrollable diabetes).
4) Down syndrome
5) Active double cancer (simultaneous double cancer, and metachronous double cancer with up to a 5-year disease-free period; carcinoma in situ determined as cured with local therapy or lesions consistent with intramucosal carcinoma are not included in double cancer.)
6) Determined as difficult to participate in the study because of complicated psychiatric disease or mental symptoms.
7) Participation in other clinical studies, excluding those of ALL, within 30 days after obtaining consent.
8) Pregnant or possibly pregnant women. Breastfeeding women. Men and women providing no consent to avoiding pregnancy during the study.
9) Previous hypersensitivity to mannitol, boron, or other components of Bortezomib.
10) Patients determined as ineligible for participation in the study by an investigator/sub-investigator for other reasons.
Target sample size
3
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
chitoseo@qb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Ito |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Clinical Research Management, Clinical Research Center
Zip code
Address
4-1-1 Sannomaru Nakaku Nagoya, Aichi, Japan
TEL
052-951-1111
Homepage URL
bzm.nagoya@nnh.go.jp
Sponsor or person
Institute
St.Luke's International Hospital
Daisuke Hasegawa
National Hospital Organization Nagoya Medical Center
Naoko Maeda
Fukushima Medical University Hospital
Atsushi Kikuta
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
| 2014 | Year | 12 | Month | 17 | 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
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 04 | Month | 21 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018581
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| Registered date | File name |
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| Registered date | File name |
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