GHSG-AFM13 An Open-label, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma (GHSG-AFM13)
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|ClinicalTrials.gov Identifier: NCT02321592|
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : November 6, 2017
The study is designed
- to demonstrate efficacy of AFM13 with an optimized treatment schedule
- to decide whether AFM13 warrants further investigation in a phase III clinical trial
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Drug: AFM13||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||GHSG-AFM13 An Open-label, Randomized, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Arm A
AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 8 consecutive weeks.
Arm A ist closed.
Active Comparator: Arm B
AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 2 consecutive weeks followed by a weekly appication 6 consecutive weeks.
Arm B is closed.
Active Comparator: Arm C
AFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks
- Objective Response Rate (ORR) [ Time Frame: at week 11 ]
- Remission status based on CT/MRI and PET-CT [ Time Frame: 3 weeks after end of treatment ]
- Progression Free Survival (PFS) [ Time Frame: 2 years ]
- Overall Survival (OS) [ Time Frame: 2 years ]
- Adverse events (AEs) including acute treatment-associated toxicities [ Time Frame: 2 years ]
- Quality of Life (QoL)-score [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321592
|Contact: Michael Fuchsfirstname.lastname@example.org|
|1st Department of Medicine, Cologne University Hospital||Recruiting|
|Contact: Michael Fuchs GHSG@uk-koeln.de|
|Principal Investigator: Andreas Engert, MD|
|Principal Investigator:||Andreas Engert, Prof.||University Hospital of Cologne|