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NCT04101331 · ClinicalTrials.gov registry record · Phase 2
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
A Phase 2 study of Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides, sponsored by Affimed.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT04101331: Completed Phase 2 study of Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides, sponsored by Affimed.
NCT04101331 is a Phase 2 study of Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides that has completed, run by Affimed. The registered enrollment target is 108 participants, roughly in line with the 103-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04101331, a Phase 2 study of Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides, has completed, sponsored by Affimed.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.
Primary Outcome
Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Conditions Studied
Interventions
- DRUG AFM13
Study Locations (20)
Other
- Royal Adelaide Hospital - Adelaide
- Flinders Medical Centre - Bedford Park
- Monash Health-Monash Medical Centre - Clayton
- Concord Repatriation General Hospital - Concord
- Gosford Hospital - Gosford
- Linear Clinical Research - Nedlands
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Bordeaux
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Los Angeles (UCLA) Health - Los Angeles
New York
- Center for Lymphoid Malignancies - New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Alabama
- University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center) - Birmingham
Georgia
- Emory University Clinic/Winship Cancer Institute - Atlanta
Louisiana
- Ochsner Clinic Foundation/Precision Cancer Therapies Program - New Orleans
Michigan
- University of Michigan Health | Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2024-01-11 |
| Phase | Phase 2 |
What the finished NCT04101331 record still lists
NCT04101331 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 103-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target.
The record links to 2 conditions, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which AFM13 is the first listed.
NCT04101331 names 20 study sites across 11 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT04101331 about?
NCT04101331 is a clinical study titled "Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides". This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct wh...
What is the current status of trial NCT04101331?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2019-11-13. Estimated completion is 2024-01-11.
What conditions does trial NCT04101331 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma, Transformed Mycosis Fungoides.
What interventions are being tested in trial NCT04101331?
The interventions under investigation include: AFM13 (DRUG).
Who is sponsoring clinical trial NCT04101331?
This trial is sponsored by Affimed, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04101331 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04101331's enrollment target sits among peer trials
108 10th of 34 higher than 25 of 34 other Peripheral T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral T-Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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