BASTION – Phase II Trial of BrECADD in HIV-Positive Patients with Advanced-Stage Classic Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 7
- 主要终点
- TRMB rate, defined as the rate of patients having any of the following adverse events (AEs) during treatment with BrECADD including a period of 30 days after the last chemotherapy dose:
研究概览
简要总结
To describe feasibility of positron-emission tomography (PET)-guided 4-6 cycles BrECADD in HIV-positive patients with AS-cHL as determined by treatment-related morbidity (TRMB).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed first diagnosis of cHL
- •Advanced-stage disease: stage IIB with large mediastinal mass and/or extranodal lesions or stage III or IV
- •Age at enrollment: 18-75 years
- •Confirmed HIV infection with CD4 counts ≥ 50/μL. Continuation of antiretroviral treatment (ART) / Initiation of ART in patients who are ART-naïve is mandatory.
排除标准
- •Nodular lymphocyte-predominant Hodgkin lymphoma, composite lymphoma, grey-zone lymphoma and/or lymphoma involvement of the central nervous system
- •Prior cHL-directed treatment except for a corticosteroid and/or cyclophosphamide pre-phase
- •Prior chemotherapy, radiotherapy or allogeneic stem cell/solid organ transplant
- •Multi-drug-resistant HIV infection or concurrent AIDS-defining conditions
- •Prior or concurrent diseases precluding protocol treatment
- •Pregnancy or breastfeeding
结局指标
主要结局
TRMB rate, defined as the rate of patients having any of the following adverse events (AEs) during treatment with BrECADD including a period of 30 days after the last chemotherapy dose:
TRMB rate, defined as the rate of patients having any of the following adverse events (AEs) during treatment with BrECADD including a period of 30 days after the last chemotherapy dose:
Acute non-hematological organ toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4
Acute non-hematological organ toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4
Acute hematological toxicity of grade 4 anemia
Acute hematological toxicity of grade 4 anemia
Grade 4 infection
Grade 4 infection
次要结局
- Adverse events
- Complete remission (CR) rate after 2 cycles and after completion of chemotherapy, respectively
- Proportion of patients receiving 4 cycles BrECADD
- Progression-free survival (PFS) and overall survival (OS) after 1 and 2 years
- Cumulative incidence of second primary malignancies after 1 and 2 years
- Patient-reported outcomes (PRO-CTCAE, quality of life; in patients providing separate informed consent)
- Therapy adherence
- Dose reductions
- CD4 lymphocyte counts during therapy
- Frequency and reasons of drop-outs
研究者
Coordinating Principal Investigator
Scientific
University Of Cologne