EUCTR2019-001003-20-IT进行中（未招募）1 期
A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients with Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT). - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Affimed GmbH
- 入组人数
- 145
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 of protocol).
- •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 tests that cannot be confirmed as negative, require a confirmatory negative serum pregnancy test. In addition, females of childbearing potential must agree use of a highly effective method of contraception (Section 6.9.1.1 of protocol) for the course of the study from 14 days prior to the first dose of study drug until 60 days after the last dose of study drug.
- •For more details please see Protocol synopsis.
- •Are the trial subje
排除标准
- •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.
研究者
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