Kaposi Sarcoma Chemotherapy and Research (KS-CARE): Clinical and Molecular Determinants of HIV-associated Kaposi Sarcoma Progression Under Local Standard-of-care Therapy in Malawi and South Africa
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This prospective, nonrandomized, open-label, single-arm, cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed HIV-associated Kaposi Sarcoma (HIV-KS). Previous HIV-KS studies demonstrated significant variability in clinical outcomes based on differences in gender or baseline KSHV DNA levels in patients with HIV-KS.
Patients will receive chemotherapy according to local site treatment guidelines and standard of care. Chemotherapy regimen for two treatments that are used locally based on physician's choice namely intravenous (IV) Paclitaxel (PTX) or the combination of Bleomycin and Vincristine (BV). In addition, all histologically proven HIV-KS could be enrolled, irrespective of their prior length of combination anti-retroviral treatment (cART). This enrolment strategy will reflect a more realistic picture of HIV-KS management.
This study result could trigger treatment alteration of HIV-KS. The treatment approaches to HIV-KS can be individualized if clinically relevant subsets and novel prognostic markers are defined. In that case, newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit, especially if prolonged treatment is needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants meeting all the inclusion criteria listed below will be eligible for screening.
- •Histologically confirmed T1 KS presenting to TBH combined Kaposi Sarcoma clinic with or without visceral disease. no evidence of improvement in human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) in the 4 weeks immediately prior; and a clinical indication for systemic chemotherapy treatment
- •Known HIV-1 infection status, as documented by any nationally approved, licensed HIV rapid test and confirmed at any time point prior by the local standard of care assay.
- •On ART or not on ART.
- •Age ≥18 years.
- •Participants able to understand and provide written informed consent in English, Afrikaans, or isiXhosa.
排除标准
- •Failure to meet the inclusion criteria listed above.
- •Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care.
- •Specifically, the absence of skin lesions is not an exclusion criterion if recorded evidence of
- •visceral or nodal disease is present in the form of a radiology or endoscopy report.
- •Participants who have had prior chemotherapy or radiotherapy for human immunodeficiency virus (HIV)-associated Kaposi Sarcoma.
- •Specifically, patients who have had prior cART will not be excluded.
- •Participants who are receiving any other investigational agents.
研究组 & 干预措施
HIV-associated Kaposi Sarcoma
Patients receive standard-of-care chemotherapy.
干预措施: standard of care chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 48 weeks
PFS will be defined as first chemotherapy day until disease progression. Mucocutaneous and visceral Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) response will be assessed separately according to protocol-defined definitions. Mucocutaneous Progressive disease (mcPD) is defined as any increase or progression in the size, type and/or number of skin and/or mucosal lesions if present at baseline or new lesion. Visceral Progressive disease (vPD) is defined as any increase in symptoms related to visceral HIV-KS if present at baseline or a new manifestation of symptoms related to visceral HIV-KS, not present at baseline, or radiological or endoscopic evidence of visceral KS, not present at baseline. Notably, lymphoedema and nodal disease will not be part of the formal response assessment for CR, PR, and SD response criteria should have been maintained for at least 4 weeks. For PD response criteria can have been present for at least 1 week.
次要结局
- Overall Survival (OS)(Up to 96 weeks)
- Progression Free Survival (PFS) - 96 weeks(Up to 96 weeks)
- Response rates (ORR)(Up to 4 weeks)
- Health-related Quality of Life (HR-QOL)(Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks)