CTRI/2024/07/069820尚未招募4 期
A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin plus Doxorubicin, Vinblastine and Dacarbazine in Indian Patients with Untreated Stage 3/4 Classical Hodgkin Lymphoma - NI
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Treatment-naïve, HL patients with Ann Arbor Stage 3 or 4 disease (Section 17.4)
- •Note: Patients must have histologically confirmed classical HL according to the current World Health Organization Classification.
- •2.Patients must have bidimensional measurable disease as documented by radiographic technique (spiral CT preferred) per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma (Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ et al. International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86).
- •3.Male or female patients 18 years or older
- •4.Eastern cooperative oncology group (ECOG) performance status =2
- •5. Female patients who
- •5.1 Are postmenopausal for at least 1 year before the screening visit, OR
- •5.2 Are surgically sterile, OR
- •5.3 If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the Informed Consent Form (ICF) through 6 months after the last dose of study drug, OR
- •5.4 Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
- •6. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
- •6.1 Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR
- •6.2 Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
- •7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- •8. Clinical laboratory values as specified below within 7 days before the first dose of study drug:
- •8.1 Absolute neutrophil count = 1,000/µL unless there is known HL marrow involvement
- •8.2 Platelet count = 75,000/µL unless there is known HL marrow involvement
- •8.3 Total bilirubin must be less than 1.5 times upper limit of the normal range (ULN) unless the elevation is known to be due to Gilbert syndrome.
- •8.4 Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) must be less than 3.0 times ULN. An AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver.
- •Note - Moderate or severe hepatic disease patients will be excluded based upon Child-Pugh criteria.
- •8.5 Serum creatinine must be less than 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance greater 30 mL/minute (Cockcroft-Gault Equation).
- •8.6 Hemoglobin must be greater than or equal to
排除标准
- •1. 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.
- •2. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.
- •3. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
- •4. Any sensory or motor peripheral neuropathy.
- •5. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
- •6. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
- •7. Previously treated with brentuximab vedotin
- •8. Any contraindications to the concomitant chemotherapy regimens (doxorubicin, vinblastine, and dacarbazine).
- •9. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of AVD (doxorubicin, vinblastine, and dacarbazine).
- •10. Known human immunodeficiency virus (HIV) positive.
- •11. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
- •12. 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 nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •13. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
- •13.1 A left-ventricular ejection fraction less than 50%
- •13.2 Myocardial infarction within 2 years of enrollment
- •13.3 New York Heart Association (NYHA) Class 3 or 4 heart failure. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •14. Any serious medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.
研究者
相似试验
进行中（未招募）
4 期
A Study of Vedolizumab in People With Ulcerative Colitis and Crohns DiseaseCTRI/2021/11/037814Ms Takeda Pharmaceutical India Pvt Ltd
招募中
4 期
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India with Osteoporosis at a High Risk of FractureCTRI/2023/03/050576Amgen Technology Pvt. Ltd.
已完成
4 期
A phase 4 safety study of pneumococcal conjugate vaccine in adults 18 to 49 yearsCTRI/2022/04/041856Pfizer Inc
尚未招募
4 期
Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in IndiaCTRI/2014/05/004608Pfizer Limited1,200
进行中（未招募）
1 期
A study on the immune response and safety of a vaccine against Neisseria meningitidis serogroup B infection in healthy infants from 2 months of ageHealthy volunteers (active immunization of infants against invasive meningococcal disease (IMD) due to N. meningitidis serogroup B infection).EUCTR2023-000764-58-Outside-EU/EEAGlaxoSmithKline Biologicals SA