UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial (Investigator-initiated clinical trial) of CH5424802 in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma
Acronym	Investigator-initiated trial of CH5424802 against relapsed or refractory ALK-positive ALCL
Scientific Title	Phase II trial (Investigator-initiated clinical trial) of CH5424802 in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma
Scientific Title:Acronym	Investigator-initiated trial of CH5424802 against relapsed or refractory ALK-positive ALCL
Region	Japan

Condition
Condition	Relapsed or refractory ALK-positive anaplastic large cell lymphoma
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy, safety, and pharmacokinetics of alectinib hydrochloride in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate determined by Independent Review Facility
Key secondary outcomes	Pharmacokinetics of CH5424802 The first safety evaluation Complete remission rate Duration of response Progression-free survival, Event free survival, Overall survival Adverse event and adverse drug reaction

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	The investigational product is administered orally at 300 mgb.i.d after breakfast and dinner for 21 days, which is regarded as 1 cycle. In subjects weighing less than 35 kg, the investigational product is administered at 150 mg b.i.d after breakfast and dinner. The administration is terminated after a maximum of 16 cycles, in principle, but may be continued over 17 or more cycles in subjects judged to require the treatment.
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	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients aged 6 years or older at consent and judged by the investigator/subinvestigator to be able to take capsules. 2) Patients definitively diagnosed with ALK-positive ALCL by histological examination. Note: Judgments are made by immunohistochemical staining of tissues collected at the initial examination or relapse. 3) Patients who can provide pathological tissues of lymphoma for central review. 4) Patients in whom the condition was judged to be PD during standard chemotherapy, CR/PR could not be achieved after the therapy, or recurrence or re-exacerbation was observed after standard chemotherapy. 5) Patients having measurable lesions defined by the Revised Response Criteria for Malignant Lymphoma according to the evaluation by the implementing medical facility. 6) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. 7) Patients expected to survive for 3 months or longer at the time of consent. 8) Patients who fulfill all the following criteria on the clinical laboratory tests at the screening examination. Those who have not been administered a genetically engineered human granulocyte colony-stimulating factor (G-CSF) preparation or have not received blood transfusion within 1 week before examination of the neutrophil and platelet counts and retain normal functions of major organs. 1.Neutrophil count: >=1,500/uL 2.Platelet count: >=75,000/uL 3.Serum bilirubin level: <1.5 times the upper limit of normal (ULN) of the facility 4.Serum creatinine level: <=1.5 times the ULN 5.Alanine aminotransferase (ALT) and aspartic aminotransferase (AST) levels: <=2.5 times the ULN 9) Written consent to participate in this clinical trial has been given by the subject in person or by a legal guardian (when the subject is younger than 20 years at consent).
Key exclusion criteria	1) Patients in whom the latest diagnosis is primary cutaneous ALCL/2)Patients in whom active viral, bacterial, or fungal infection has been observed within 2 weeks before the first administration of the investigational product/3) Patients with poorly controlled diabetes/4) Patients with a history or complication of another malignant neoplasm that has not been cured for 3 years or longer/5) Patients with CNS lesions/6) Patients showing signs or symptoms suggestive of PML/7) Patients with a history of severe hypersensitivity or allergy/8) Patients positive for HIV antibody, HBs antigen, HBs antibody, HBc antibody, or HVC antibody/9) Patients with liver cirrhosis/10) Patients who have received ASCT within 12 weeks before the first administration of the investigational product/11) Patients who have received allogeneic hematopoietic stem-cell transplantation/12) Patients who have received treatment for a malignant neoplasm within 4 weeks before the first administration of the investigational product/13) Patients who have been administered an adrenocorticosteroid hormone preparation for the treatment of lymphoma within 7 days before the first administration of the investigational product./14) Patients administered another investigational product or treated using an investigational instrument within 4 weeks./15) Patients who received a treatment specifically targeting ALK in the past./16) Patients known to have hypersensitivity to additives contained in the investigational product./17) Patients who are pregnant, breast-feeding, or may be pregnant, or do not consent to contraception for 6 months after the last administration of the investigational product./18) Patients who have a disability that impairs their ability to consent in writing or conform to the trial procedure./19) Patients who have been judged by the investigator to be inappropriate for participation in this clinical trial for other reasons.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hirokazu Middle name Last name Nagai
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Hematology and Oncology Research, Clinical Research Center
Zip code	4600001
Address	4-1-1 Sannomaru Nakaku Nagoya, Aichi, Japan
TEL	052-951-1111
Email	nagaih@nnh.hosp.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 Management, Clinical Research Center
Zip code	4600001
Address	4-1-1 Sannomaru Nakaku Nagoya, Aichi, Japan
TEL	052-951-1111
Homepage URL
Email	alc.office@nnh.go.jp

Sponsor
Institute	National Hospital Organization Nagoya Medical Center Hirokazu Nagai St.Marianna University School of Medicine Hospital Tetsuya Mori National Hospital Oganization Kyusyu cancer center Che Irusun
Institute
Department

Funding Source
Organization	Chugai Inc.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya Medical Center
Address	4-1-1,Sannomaru,Naka-ku,Nagoya-shi Aichi-ken,Japan
Tel	052-951-1111
Email	study.office@nnh.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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 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	10
Results	in preparation
Results date posted	2019 Year 04 Month 03 Day
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	Main results already published
Date of protocol fixation	2015 Year 02 Month 18 Day
Date of IRB	2015 Year 03 Month 12 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 04 Month 11 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2020 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019718