EUCTR2019-001003-20-PL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).
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
- 108
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 centrally assessed Ber-H2
- •targeted IHC; cut-offs listed in protocol) PTCL (allowed subtypes listed
- •in protocol) or TMF per the revised WHO 2016 classification (Swerdlow,
- •2016) by central assessment (Note: Subjects must wait for central
- •results before first dose of study drug). The PTCL subtypes allowed for Cohorts A and B as described in protocol
- •section 3.1. The required cut-offs for the CD30-positivity are described in protocol
- •section 3.1.
- •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. Note: After the planned Interim Analyses,
- •Cohorts A and B may be combined with the CD30-positivity defined as =
- •1% by centrally assessed IHC.
- •4. Subjects must have relapsed or refractory disease AND the following:
- •Cohorts A and B (PTCL cohorts): subjects must have received at least 1
- •prior line of systemic therapy. For subjects with systemic ALCL, subjects
- •must have failed or be intolerant to brentuximab vedotin [BV];
- •Cohort C (TMF cohort): subjects must have received at least 1 prior
- •line of systemic therapy, and have exhausted systemic therapies with
- •full approval for their treatment of transformed mycosis fungoides.
- •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.
- •Note: subjects may be enrolled after a minimum of 2 weeks post radiation
- •if radiation was for palliative intent to a single cutaneous lesion or single
- •nodal region after discussion with the Sponsor.
- •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 previous therapy-related
- •toxicity to =Grade 1 or to baseline if pre-existing condition (exception:
- •subjects with all grade alopecia and =Grade 2 peripheral neuropathy).
- •8. Eastern Cooperative Oncology Group (ECOG) performance score of 0
- •9. Life expectancy =12 weeks.
- •10. Adequate laboratory functional values. (Note: transfusions and
- •growth factors allowed during Screening; however,
- •transfusion dependency defined as requiring blood products >once per
- •week not allowed):
- •a) Platelet count =50,000/mm3;
- 另有 7 项未显示
排除标准
- •1. Subjects 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 gastrointestinal tract
- •Adult T-cell leukemia/lymphoma
- •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: Subjects 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 chronic systemic immunosuppressive therapy <12 weeks prior to the first dose of study drug for
- •prophylaxis or management of conditions such as GvHD (eg,
- •mycophenolate, methotrexate, calcineurin inhibitor based therapy,
- •steroid doses that would require prolonged tapering for
- •discontinuation).
- •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 subject from participation in the study
- •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 II, III, IV; Appendix C of protocol), myocardial infarction =6 months prior to first study drug,
- •uncontrolled cardiac arrhythmia eg, 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) active Hepatitis B or Hepatitis C as defined in the protocol. Antiviral
- •prophylaxis for chronic Hepatitis B virus infection may be used at the
- •discretion of the investigator. Note: Subjects must meet criteria defined
- •in the protocol to be allowed to be enrolled in the study).
- •7. Diagnosis 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 (outside of
- •examples already mentioned in exclusion criterion number 4) <7 days
- •prior to the first dose study drug. Topical steroid creams for
- •symptomatic relief for subjects 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
- •10. General intolerance of any protocol medication or its excipients.
- •11. Subject´s inability to appreciate the nature, meaning and
- •consequences of the trial and to formulate his/her own wishes
- •correspondingly.
- •12. Subject 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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