Phase II trial (Investigator-initiated clinical trial) of CH5424802 in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma - Investigator-initiated trial of CH5424802 against relapsed or refractory ALK-positive ALC

ational Hospital Organization Nagoya Medical Center Hirokazu Nagai St.Marianna University School of Medicine Hospital Tetsuya Mori National Hospital Oganization Kyusyu cancer center Che Irusun0 sites10 target enrollmentApril 1, 2015

ConditionsRelapsed or refractory ALK-positive anaplastic large cell lymphoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Relapsed or refractory ALK-positive anaplastic large cell lymphoma
Sponsor: ational Hospital Organization Nagoya Medical Center Hirokazu Nagai St.Marianna University School of Medicine Hospital Tetsuya Mori National Hospital Oganization Kyusyu cancer center Che Irusun
Enrollment: 10
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

in preparation

Registry

who.int

Start Date

April 1, 2015

End Date

March 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

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

Eligibility Criteria

Inclusion Criteria

Not provided

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.