Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 12:50 AM
Study NCT ID:
NCT05683704
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-01-13
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Multi-center Randomized Study to the Efficacy and Safety of AK105 Combined With Anrotinib Hydrochloride in Patients With Recurrent/Refractory Classical Hodgkin's Lymphoma
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
Phase 2 Multi-center Randomized Study to the Efficacy and Safety of AK105 Combined With Anrotinib Hydrochloride in Patients With Recurrent/Refractory Classical Hodgkin's Lymphoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single arm, open, multi center phase II exploratory study. To evaluate the efficacy and safety of AK105 combined with androtinib hydrochloride capsule in patients with relapsed/refractory classical Hodgkin's lymphoma (relapse or progression after autologous stem cell transplantation, or relapse progression after autologous stem cell transplantation but ≥ 1 line systemic multi drug combination chemotherapy). After screening, the subjects met the inclusion criteria and did not meet the exclusion criteria, and then entered the treatment period. They received AK105 injection (once every three weeks, 200mg/time, intravenous infusion) combined with androtinib hydrochloride capsule (once a day, 10mg each time, and stopped for one week for two consecutive weeks). Every 21 days was a treatment cycle until disease progression/intolerance occurred or the sponsor terminated the study. Patients with complete remission (CR) continue to receive 4 cycles of treatment, and then further consolidate treatment every 9 weeks within 1 year of continuous CR, and can stop treatment after 1 year of continuous CR. At the end of the trial, the subjects who can still benefit from the study treatment as judged by the investigator will continue to be provided with the trial drug. The longest administration time of AK105 combined with androtinib hydrochloride capsules shall not exceed 2 years.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: