Status:
COMPLETED
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Lead Sponsor:
Affimed GmbH
Conditions:
Peripheral T Cell Lymphoma
Transformed Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 te...
Eligibility Criteria
Inclusion
- Main
- Histologically confirmed CD30-positive PTCL (most subtypes allowed) or TMF per the revised World Health Organization 2016 classification (Swerdlow, 2016) by central assessment.
- Cohorts A and B (PTCL cohorts): measurable by the modified Lugano Classification (Cheson, 2014); measurable disease of ≥1.5 cm diameter by computed tomography (CT), assessed locally for eligibility. Note: fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) recommended, if possible.
- Cohort C (TMF cohort): measurable by the Olsen Criteria (Olsen, 2011) including at least 1 cutaneous lymphoma lesion ≥2 cm in diameter, assessed locally for eligibility.
- Patients must have relapsed or refractory disease AND the following:
- Cohorts A and B (PTCL): patients must have received at least 1 prior line of systemic therapy. For patients with systemic ALCL, patients must have failed or be intolerant to brentuximab vedotin \[BV\]; Adcetris®
- Cohort C (TMF): patients must have received at least 1 prior line of systemic therapy; and have exhausted systemic therapies with regular approval for their disease
- Main
Exclusion
- Patients with the following subtypes of lymphoma: T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; Chronic lymphoproliferative disorder of NK cells; Aggressive NK-cell leukemia; Extranodal NK-/T-cell lymphoma; Indolent T-cell lymphoproliferative disorder of the GI tract:
- Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Patients who have had a transplant \>3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD).
- Requirement for systemic immunosuppressive therapy, e.g. GvHD therapy, \<12 weeks prior to the first dose of study drug.
- Prior treatment with AFM13
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04101331
Start Date
November 13 2019
End Date
January 11 2024
Last Update
November 5 2024
Active Locations (69)
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1
University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
Birmingham, Alabama, United States, 35294
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
University of California Los Angeles (UCLA) Health
Los Angeles, California, United States, 90404
4
Emory University Clinic/Winship Cancer Institute
Atlanta, Georgia, United States, 30322