Phase II trial (Investigator-initiated clinical trial) of CH5424802 in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma
- Conditions
- Relapsed or refractory ALK-positive anaplastic large cell lymphoma
- Registration Number
- JPRN-UMIN000016991
- Lead 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
- Brief Summary
in preparation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate determined by Independent Review Facility
- Secondary Outcome Measures
Name Time Method 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