NCT01352520进行中（未招募）2 期
Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can help to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The safety of the study drug will also be studied.
详细描述
The Study Drug:
Brentuximab vedotin is an antibody that is designed to find a certain protein (called CD30) on cancer cells and bind to it. It is designed to then enter the cell and release a molecule that may kill the cancer cells.
Study Drug Administration:
If you are found eligible to take part in this study, you will begin receiving brentuximab vedotin by vein over 30 minutes on Day 1 of each 21-day study cycle. If you have side effects after your first dose and your doctor thinks it is in your best interest, future doses may be lowered or delayed for up to 3 weeks.
Premedications:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •1. Patients must have a biopsy confirmed diagnosis based on a combination of histological and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for the phase II trial. There is no specific limit or validated amount other than positive cells on 1HC cells in tumor cells.
- •2. Patients with pc-ALCL that has spread systemically (e.g. to lymph nodes, bone marrow or visceral organs) may be included so long as pc-ALCL was the primary diagnosis for at least 6 months before systemic involvement was confirmed. MF patients must be stage IB or greater.
- •3. Systemic involvement (i.e., nodal, bone marrow or visceral organ involvement) will be evaluated by CT and/or PET and bone marrow biopsy(if indicated on patients with blood involvement) in patients with pc-ALCL or MF at baseline.
- •4. Patients' biopsies must be histologically confirmed CD30 positive within 36 months of enrollment.
- •5. pc-ALCL and MF patients must have progressed or relapsed after treatment with local radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy of at least one single agent (e.g., methotrexate or bexarotene or other non-CD30 antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone). pc-ALCL classified patients are required to have one or more cutaneous tumors that by history have been present for at least 3 months.
- •6. All patients must be considered an eligible candidate for systemic therapy as determined by the investigator. To be eligible, LYP patients must be in need of systemic therapy ie have scarring or active lesions (\>/=10 per month), or any number of active lesions on face, hands or feet.
- •7. Patients must have the following minimum wash-out from previous treatments: a. \>/= 4 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anticancer investigational agents. b. \> 2 weeks for oral methotrexate, retinoids or biological response modifiers therapy for any indication, or topical prescription or topical therapy. c. \>/= 12 weeks for any immunotherapy (e.g., monoclonal antibody). Patients with rapidly progressive disease may be treated earlier than the required washout period; patients should have recovered from prior treatment-related toxicities
- •8. Patients must have an ECOG performance status of \/= 1000/microliter, platelets \>/= 50,000/µL (unless documented bone marrow involvement with lymphoma), bilirubin \
排除标准
- •Concomitant corticosteroid use for systemic or topical treatment of skin disease is not allowed except a dose of steroid of no more than 20 mg of prednisone or its equivalence is allowed of asthma, COPD or IBD .Stable use of topical corticosteroids of mid-potency will be allowed for patients with erythroderma-Sezary syndrome (T4) and tumor stage (T3) with intense pruritus.
- •Patients with known grade 3 or higher (per CTCAE v.4.0 criteria) active systemic or cutaneous viral, bacterial or fungal infection.
- •Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
- •Patients with known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation that includes trehalose, sodium citrate, and polysorbate
- •Patient with a history of other malignancies during the past three years. (The following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
- •Patients with congestive heart failure, Class III or IV, by the NYHA criteria.
- •Patients who are pregnant or breastfeeding.
- •Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- •Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
研究组 & 干预措施
SGN-35
Experimental
1.8 mg/kg intravenously Day 1 of 21-day cycle.
干预措施: SGN-35 (Drug)
结局指标
主要结局
Response Rate
时间窗: 12 months
Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
次要结局
- Time to Progression(Assessments through 8 treatment cycles (21 day cycle, approximately 6 months) with possible expansion to 16 cycles, up to 2 years.)
研究者
研究点 (1)
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