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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

NCT05683704 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

  • Recurrent/Refractory Classical Hodgkin's Lymphoma

Interventions

DRUG

AK105，Anrotinib hydrochloride

AK105 administered IV at day 1 every 3 weeks for 8-12 cycles Anrotinib administered PO at day 1-14 every 3 weeks for 8-12 cycles

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683704 on ClinicalTrials.gov