EUCTR2019-001003-20-ES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).
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
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).
- •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
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
相似试验
进行中（未招募）
1 期
Studio per valutare la sicurezza e l'efficacia di AFM13 in pazienti con alcuni tipi di linfoma a cellule TRelapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis FungoidesMedDRA version: 21.1Level: PTClassification code 10034623Term: Peripheral T-cell lymphoma unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-001003-20-ITAffimed GmbH145
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of AFM13 in patients with certain types of T-cell lymphomaEUCTR2019-001003-20-PLAffimed GmbH108
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of AFM13 in patients with certain types of T-cell lymphomaRelapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis FungoidesMedDRA version: 20.0Level: HLTClassification code 10034622Term: Peripheral T-cell lymphomas NECSystem Organ Class: 100000004851MedDRA version: 20.0Level: HLTClassification code 10028484Term: Mycoses fungoidesSystem Organ Class: 100000004851EUCTR2019-001003-20-DEAffimed GmbH108
进行中（未招募）
1 期
A study to test the safety and effects of IMG-7289 in patients with essential thrombocythemiaPatients with essential thrombocythemiaMedDRA version: 21.0Level: LLTClassification code 10015494Term: Essential thrombocythemiaSystem Organ Class: 100000004864EUCTR2019-003659-13-ITImago BioSciences, Inc60
进行中（未招募）
1 期
A study to test the safety and effects of IMG-7289 in patients with essential thrombocythaemia.Patients with essential thrombocythaemiaMedDRA version: 21.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-003659-13-GBImago BioSciences Inc.60