A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- NK/T Cell Lymphoma
- Peripheral T Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: ATG-010 + ICE ATG-010 + GEMOXMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This trial is a single-arm, open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin) sequential ATG 010 monotherapy maintenance, t...
This trial is a single-arm, open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. Thirty patients are planned to be enrolled (about 50% of patients will be enrolled in ICE and GEMOX, respectively), among which, no more than 5 patients will be enrolled in type of NK/T-cell lymphoma.
Tracking Information
- NCT #
- NCT04425070
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Huiqiang Huang, MD; PhD Sun Yat-sen University
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