EUCTR2005-005547-26-DE进行中（未招募）1 期
An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients with Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma - Not Available
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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. Patient or guardian must have read, understood, and provided written informed consent after the nature of the study has been fully explained. Patients 12 through 17 years old must also provide written assent
- •2. Confirmed diagnosis of ALCL (excluding HIV-associated ALCL)
- •3. Patients with csALCL must have a histologically confirmed diagnosis of CD30+ ALCL and confirmation of anaplastic lymphoma kinase status (positive or negative)
- •4. Patients with csALCL must have failed or relapsed following second line chemotherapy or relapsed or failed following autolougus stem cell transplant. Patients who are not candidates for stem cell transplant, exhibitit chemo-resistant disease, or refuse further chemotherapy may also be included.
- •5. Patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen
- •6. Patients with pcALCL must have a histologically confirmed diagnosis of CD30+ ALCL within the past 12 months
- •7. ECOG Performance Status of 0 to 2
- •8. Patients must have bidirectionally measurable disease
- •9. At least 4 weeks since the last chemotherapy or radiation therapy prior to dosing of MDX-060 and have recovered from any toxicity associated with such treatment or returned to baseline
- •10. At lease 12 years of age
- •11. Life expectancy of 12 weeks or more
- •12. Screening laboratory valuse must meet criteria
- •13. Women must either be post-menopausal for at least 1 year, surgically incapable of bearing children, or utilizing a reliable form of contraception. All women must have a negative pregnancy test during screening
- •14. Men must agree to the use of male contraception for the duration of the study
- •15. Patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until Day 365
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous treatment with any anti-CD30 antibody
- •2. History of allogenic transplantation
- •3. Any tumor lesion 10cm or greater in diameter
- •4. Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease-free for at least 5 years is permissible
- •5. Any significant active or chronic infection
- •6. Prior known serum positivity for HIV antibodies, hepatitis B antigenemia, or hepatitis C veremia, as determined at screening
- •7. Treatment with investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening
- •8. Apparent active or latent tuberculosis infection
- •9. Patients who are pregnant or nursing
- •10. Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events
- •11. Concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy
- •12. Patients with mycosis fungoides
- •13. Patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL
研究者
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