Relapsed or refractory ALK-positive anaplastic large cell lymphoma
Conditions
Interventions
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 produc
Sponsors
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
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate determined by Independent Review Facility | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYutaka Ito
National Hospital Organization Nagoya Medical Center Department of Clinical Research Management, Clinical Research Center
Outcome results
None listed