Phase II Study To Assess AFM13 In Patients With R/R CD30-positive T-cell Lymphoma Or Transformed Mycosis Fungoides

Overview

About this study

The purpose of this study is to learn about the effects of a research medicine called AFM13 and to see how well AFM13 is tolerated.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nabila Bennani, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available