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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033351
Receipt No. R000037897
Scientific Title A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
Date of disclosure of the study information 2018/07/20
Last modified on 2018/09/18

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Basic information
Public title A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
Acronym A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
Scientific Title A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
Scientific Title:Acronym A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
Region
Japan

Condition
Condition Relapsed or refractory CD22-positive ALL
Relapsed or refractory CD22-positive lymphoblastic lymphoma and bone marrow involvement
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and tolerability of inotuzumab ozogamicin in pediatric subjects in Japan with relapsed/refractory CD22 positive ALL/Lymphoblastic Lymphoma (referred to as ALL) in order to select the recommended clinical dose.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Incidence of first cycle dose limiting toxicities (DLTs) of inotuzumab ozogamicin
Key secondary outcomes 1) PK profile of inotuzumab ozogamicin
2) Safety profile, including VOD/SOS
3) Complete remission rate (CR/CRi )
4) Minimal residual disease (MRD) status in patients achieving a CR/CRi
5) Overall survival (OS)

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 For the dose level 1 (starting dose), pediatric patients with ALL will be treated with 1.8 mg/m2 inotuzumab ozogamicin per cycle with a fractionated dose regimen. Patients will receive 0.8 mg/m2 on Day 1, followed by 0.5 mg/m2 on Day 8 and Day 15. 1 cycle is 21 days for Cycle 1 and 28 days for Cycle 2 and after. For Cycle 2 and after, the dose of inotuzumab ozogamicin on Day 1 will be reduced to 0.5 mg/m2 (for a total cycle dose of 1.5 mg/m2) in patients who achieve a CR or CRi. If patients have not achieved CR or CRi after the first cycle, the same dose as Cycle 1 will be used (for a total cycle dose of 1.8 mg/m2). The dose levels -1 and -2 will be used according to the same schedule as that for the dose level 1.
For patients who may not undergo HSCT, it is recommended that treatment with inotuzumab ozogamicin be limited to 6 cycles, but the treatment will be discontinued if CR/CRi not achieved within 3 cycles. For patients who may undergo HSCT, since the risk of VOD/SOS may increase in accordance with the increasing number of cycles, the treatment must be up to a minimum number of cycles at which patients gain benefit. The treatment should be up to 3 cycles unless more treatment is considered to be necessary.
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
17 years-old >=
Gender Male and Female
Key inclusion criteria 1. Relapsed or refractory CD22-positive ALL (>=5% marrow blasts, assessed by morphology) due to receive either salvage 1 or salvage 2 therapy, or relapsed or refractory CD22-positive lymphoblastic lymphoma and bone marrow involvement >=5% lymphoblasts by morphologic assessment.
2. Ph+ ALL patients must have failed treatment with at least 1 second or third generation tyrosine kinase inhibitor and standard multi-agent induction chemotherapy;
3. Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy;
4. Patients from 1 to 17 years old at the timing of informed consent.
5. Karnofsky performance status 60% to 100% for patients >=17 years of age and Lansky performance status 60% to 100% for patients <=16 years of age
6. Adequate liver function, including total serum bilirubin <=1.5 x ULN unless the patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase (AST and ALT) <=2.5 x ULN. If organ function abnormalities are considered due to tumor, total serum bilirubin must be <=2 x ULN and AST/ALT <=2.5 x ULN. Pediatric reference ranges will be used.
7. Serum creatinine <=1.5 x upper limit of normal (ULN) (pediatric reference ranges will be used) or estimated creatininee clearance of >=40 mL/min by standard calculation method of site.
8. Pregnant, lactating, childbearing potential female or childbearing potential male must agree to use a highly effective method of contraception throughout the study and for a minimum of 90 days after the last dose of treatment.
9. Evidence that an informed consent document personally signed and dated by the patient or the legal representative such as parents indicates that the patient has been informed of all pertinent aspects of the study before any study specific activity is performed;
10. Patients who are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
11. Asian patient.
Key exclusion criteria 1. Isolated extramedullary relapse (testicular or CNS)
2. Burkitt's or mixed phenotype acute leukemia (WHO 2008 criteria)
3. Active central nervous system leukemia. Prophylactic intrathecal medication is not excluded.
4. Having undergone prior chemotherapy at enrollment excluding therapy to reduce the circulating lymphoblast count or palliation: steroids, hydroxycarbamide, or vincristine
5. Prior administration of monoclonal antibodies within 4 weeks of enrollment
6. Prior rituximab treatment at enrollment
7. Prior allogeneic HSCT or other anti-CD22 immunotherapy <=4 months before enrollment
8. Having completed immunosuppression therapy in GvHD prior to enrollment. With >= Grade 2 acute GvHD, or extensive chronic GvHD at enrollment
9. Systemic vasculitides, or primary or secondary immunodeficiency
10. Active HbsAg B or HCV C infection or seropositivity for HIV
11. Major surgery within <=4 weeks before enrollment
12. Unstable or severe uncontrolled medical condition
13. Concurrent active malignancy excluding non-melanoma skin cancer that has been definitely treated with radiation or surgery, calculated cervical high grade squamous intraepithelial lesion (CIN2, CIN3), or localized prostate cancer. Those with previous malignancies in disease free for >=2 years
14. <45% cardiac function (left ventricular ejection fraction), or class >=3 (Modified Ross Heart Failure Classification)
15. Active heart disease
16. Myocardial infarction <=6 months before enrollment
17. History of chronic liver disease
18. History of hepatic veno-occlusive disease or sinusoidal obstruction syndrome
19. Live vaccine administration <=6 weeks before enrollment
20. Evidence of serious active infection
21. History of severe allergic or anaphylactic reaction to any humanized monoclonal antibodies
22. Participation in other studies
23. History of Inotuzumab ozogamicin administration
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keizo Horibe
Organization National Hospital Organization Nagoya Medical Center
Division name Clinical Research Center
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL 052-951-1111
Email keizo.horibe@nnh.go.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 Planning and Management, Clinical Research Center
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL 052-951-1111
Homepage URL
Email study.office@nnh.go.jp

Sponsor
Institute National Cancer Center Hospital
Nagoya Medical Center
Osaka City General Hospital
Kyushu Cancer Center
Institute
Department

Funding Source
Organization Pfizer Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 国立がん研究センター中央病院(東京都)
名古屋医療センター(愛知県)
大阪市立総合医療センター(大阪府)
九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 20 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
2018 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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