NL-OMON37406已完成2 期
A Phase I/II Study of brentuximab vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma - Brentuximab Vedotin (SGN-35)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Male or female patients aged 2 to < 18 years (5 to < 18 years for patients with HL).;2. Have a diagnosis of systemic anaplastic large-cell lymphoma, or Hodgkin lymphoma for which standard, curative, life-prolonging, or palliative treatment does not exist or is no longer effective. (Patients diagnosed with any relapsed or refractory CD30+ hematological malignancy [eg, primary mediastinal B-cell lymphoma] may be included in phase 1 of the study.);3. Patients with sALCL must have documented anaplastic lymphoma kinase (ALK) status.;4. Patients with HL must be in their second or later relapse, have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell transplant.;5. Patients with relapsed or refractory sALCL must be beyond first remission or refractory to front-line chemotherapy.;6. Performance score >= 60 from Lansky Play Performance Scale if <= 16 years;7. Female patients who are of childbearing potential, agree to practice 2 effective
- •methods of contraception, at the same time, from the time of signing the informed
- •consent form (ICF) through 6 months after the last dose of study drug, or agree to
- •completely abstain from heterosexual intercourse;8. Male patients, even if surgically sterile, who agree to practice effective barrier
- •contraception during the entire study treatment period and through 6 months after the
- •last dose of study drug, or agree to completely abstain from heterosexual intercourse;9. Voluntary written consent (and institution-specific assent as appropriate based upon
- •patient comprehension) must be given before performance of any study-related
- •procedure not part of standard medical care, with the understanding that
- •consent/assent may be withdrawn by the patient or patient guardian at any time
- •without prejudice to future medical care.;10. Suitable venous access for the study-required procedures.;11. Clinical laboratory values as specified below within 14 days before the first dose of
- •study drug:
- •Absolute neutrophil count greater than or equal to 1,500/µL.
- •Platelet count greater than or equal to 75,000/µL.
- •Serum bilirubin level less than or equal to 1.5 * upper limits of normal (ULN).
- •Serum creatinine less than or equal to 1.5 * ULN.
- •Alanine aminotransferase (ALT or SGPT) and aspartate aminotransferase (AST
- •or SGOT) less than or equal to 2.5 * ULN.;12. Patients must have a radiographically or clinically evaluable tumor per the IWG(1)
排除标准
- •1. Current diagnosis of primary cutaneous ALCL those with systemic ALCL are
- •2. Received an allogeneic stem cell transplant < 6 months prior to first dose of study
- •medication, or presence of polymerase chain reaction (PCR)-detectable CMV in any
- •post-allogeneic transplant patient. (Prior PCR positivity that was successfully treated
- •is acceptable provided the baseline PCR result is negative prior to first dose of study
- •3. Receiving immunosuppressive therapy.
- •4. Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is
- •5. Previous treatment with any anti-CD30 antibody.
- •6. Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma half lives.
- •7. Symptomatic cardiac disease including ventricular dysfunction, coronary artery
- •disease, or arrhythmias, if this would, in the opinion of the investigator or medical
- •monitor, interfere with assessment of efficacy or safety of the drug.
- •8. History of another primary malignancy not in remission for at least 3 years. (The
- •following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical
- •carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear)
- •9. Known cerebral/meningeal disease, including signs or symptoms of
- •progressive multifocal leukoencephalopathy (PML).
- •10. History of cirrhosis.
- •11. Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral
- •therapy or antifungal therapy within 2 weeks prior to first dose of study drug (routine
- •antimicrobial prophylaxis is acceptable).
- •12. Concurrent therapy with other anti-neoplastic or experimental agents.
- •13. System corticosteroid therapy <14 days prior to first dose of study medication.
- •14. Any serious underlying medical condition that, in the opinion of the investigator or
- •medical monitor, would impair patient*s ability to receive or tolerate the planned
- •15. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient
- •contained in the drug formulation.
- •16. Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks
- •prior to first study dose.
- •17. Prior autologous hematopoietic stem cell infusion < 6 weeks prior to first study dose.
- •18. Grade 2 or greater unresolved toxicity from prior antineoplastic therapy.
- •19. Received a strong inhibitor of CYP3A4 < 2 weeks prior to first study dose.
研究者
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