A study to evaluate the safety and efficacy of AFM13 in patients with certain types of T-cell lymphoma
- Conditions
- Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis FungoidesTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001003-20-ES
- Lead Sponsor
- Affimed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 145
1. Written informed consent in accordance with federal, local, and institutional guidelines.
2. Age =18 years at time of provision of informed consent.
3. Histologically confirmed CD30-positive (via Ber-H2 targeted assay;cut-offs listed in protocol) PTCL (allowed subtypes listed in protocol) or TMF per the revised WHO 2016 classification (Swerdlow, 2016) by central assessment.
The required cut-offs for the CD30-positivity are:
• Cohort A (PTCL): =10% by IHC • Cohort B (PTCL): =1 to <10% by IHC • Cohort C (TMF): =1% by IHC
Measurable disease will be defined as below for each cohort:
• 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.
• 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.
4. 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.
Note: intolerance is defined as a discontinuation of a drug due to a =Grade 2 treatment-related adverse event that is clearly documented.
5. Completion of treatment with any radiotherapy, chemotherapy, antibody, immunoconjugates and/or another investigational drug =4 weeks (or 5 half-lives of the drug, whichever is shorter) prior to first dose of study drug.
6. Completion of an autologous hematopoietic stem cell transplantation at least 3 months prior to first dose of study drug (if applicable).
7. Resolution of any clinically significant therapy-related toxicity to =Grade 1 or to baseline if pre-existing condition (exception: patients with =Grade 2 peripheral neuropathy will be allowed).
8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 (Appendix B).
9. Life expectancy =12 weeks.
10. Adequate laboratory functional values:
a) Platelet count =50,000/mm3;
b) Hemoglobin =8.0 g/dL (=4.96 mmol/L);
c) Absolute neutrophil count >1,000/mm3;
d) Alanine transaminase/aspartate transaminase =3 x the upper limit of normal (ULN) or =5 x for patients with documented hepatic involvement with lymphoma;
e) Total bilirubin =1.5 x ULN or <3 x ULN for patients with Gilbert’s disease or documented hepatic involvement with lymphoma;
f) Serum creatinine =1.5 mg/dL or measured or calculated (per institutional standard) creatinine clearance =30 mL/min for patients with creatinine levels >1.5 x ULN;
11. If female of child-bearing potential, must not be pregnant or be breastfeeding and required to have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug. Note: Urine pregnancy tes
1. 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 (ATLL).
•Indolent T-cell lymphoproliferative disorder of the GI tract
2. Current evidence of central nervous system involvement.
3. 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).
4. Requirement for systemic immunosuppressive therapy e.g. GvHD therapy, <12 weeks prior to the first dose of study drug.
5. Major surgery =4 weeks prior to first dose of study drug.
6. Any active, concurrent, significant illness or disease (other than T-cell lymphoma) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participation in the study such as:
a) active infection requiring systemic therapy =10 days before the first dose of study drug;
b) unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] II, III, IV; Appendix C of protocol).
C), myocardial infarction =6 months prior to first study drug, uncontrolled cardiac arrhythmia e.g. atrial fibrillation/flutter, cerebrovascular accidents =6 months before first dose of study drug;
c) any severe or uncontrolled other disease or condition which might increase the risk associated with study participation;
d) known active Hepatitis B e.g. hepatitis B surface antigen reactive, or Hepatitis C e.g. hepatitis C virus RNA (qualitative) is detected.
7. Known history of Human Immunodeficiency Virus (HIV) i.e. presence of HIV 1/2 antibodies.
8. Diagnosis of immunodeficiency or requirement for systemic steroid therapy or any other form of immunosuppressive therapy <7 days prior to the first dose study drug. Topical steroid creams for symptomatic relief for patients in Cohort C (TMF) are exceptions to this rule. Also, the use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor/Medical Monitor.
9. Any other malignancy known to be active, with the exception of treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
10. General intolerance of any protocol medication or its excipients.
11. Patient´s inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly.
12. Patient is unwilling to comply with the protocol; including the required biopsies and PK sampling.
13. Prior treatment with AFM13.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method