UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033351
Receipt number 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 2021/07/12 14:30:14

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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), 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 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 Keizo
Middle name
Last name Horibe

Organization

National Hospital Organization Nagoya Medical Center

Division name

Clinical Research Center

Zip code

460-0001

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 Yutaka
Middle name
Last name Ito

Organization

National Hospital Organization Nagoya Medical Center

Division name

Department of Clinical Research Planning and Management, Clinical Research Center

Zip code

460-0001

Address

4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan

TEL

052-951-1111

Homepage URL


Email

study.office@nnh.go.jp


Sponsor or person

Institute

National Cancer Center Hospital
Nagoya Medical Center
Osaka City General Hospital
Kyushu Cancer Center
Hyogo Prefectural Kobe Children's Hospital

Institute

Department

Personal name



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

National Hospital Organization Nagoya Medical Center Institutional Review Board

Address

4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan

Tel

052-951-1111

Email

311-chiken@mail.hosp.go.jp


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)
兵庫県立こども病院(兵庫県)


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

Completed

Date of protocol fixation

2018 Year 06 Month 20 Day

Date of IRB

2018 Year 07 Month 20 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2021 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

2021 Year 07 Month 12 Day



Link to view the page

Value
https://center6.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
Registered date File name