EUCTR2020-002382-33-PL进行中（未招募）1 期
Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles- RAFTING
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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. Male or female patients aged 18-70.
- •2. Treatment-naïve, classical HL patients with Ann Arbor stage I or II A non-bulky disease stratified according to modified EORTC Criteria (refer to Appendix A);
- •3. Patients must have histologically confirmed classical HL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocytes rich, lymphocytes depleted, or classical HL NOS [not otherwise specified];
- •4. ECOG performance status 0-2
- •5. Hemoglobin must be > 8 gr./dL
- •6. Absolute neutrophil count = 1,000/µL
- •7. Platelet count = 100,000/µL
- •8. Voluntary written consent to take part to the study
- •9. Serum Creatinine < 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance > 40 mL/minute
- •10. Total bilirubin must be < 2.0 x the upper limit of normal (ULN) unless known Gilbert syndrome
- •11. ALT or AST must be < 3 x the upper limit of normal.
- •12. Female patients: if postmenopausal for at least 1 year before enrolment or, if fertile - agreeing to practice 2 effective methods of contraception or agreeing to practice true abstinence.
- •13. Male patients should agree to practice barrier contraception or to practice abstinence
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 162
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma;
- •2. Bulky disease (Lugano 2014 definition: single or conglomerated nodal mass with the largest diameter measuring 10 or more centimeters);
- •3. B symptoms;
- •4. Extra nodal site involved by disease;
- •5. Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug;
- •6. Uncompensated diabetes mellitus requiring insulin therapy;
- •7. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol;
- •8. Known human immunodeficiency virus (HIV) infection with a positive search for HIV antigens by immunoblot and/or circulating copies of HIV-RNA;
- •9. Active hepatitis B with circulating copies of HBV-DNA, or active hepatitis C infection with circulating copies of HCV-RNA;
- •10. Severely impaired, lung and renal function;
- •11. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection;
- •12. Active autoimmune disorder in treatment with immunosuppressive drugs
- •13. A left-ventricular ejection fraction < 50%;
- •14. Myocardial infarction within 2 years of study entry.
- •15.Pregnancy or lactation
研究者
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