EUCTR2017-001468-39-DE进行中（未招募）1 期
Phase 1b trial evaluating idelalisib in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma or mediastinal B-cell lymphoma in combination with RICE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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) Male or female subjects 1 to less than 18 years of age
- •2) Histologically confirmed diagnosis of DLBCL, or MBCL established by the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissues
- •3) Relapsed or refractory DLBCL or MBCL
- •a) Refractory disease is defined as a < 50% decrease in lesion size with first-line therapy.
- •b) Relapsed reflects progressive disease or the appearance of new lesions after attainment of complete or partial remission.
- •c) Subjects who fail first line therapy may be categorized into 3 distinct groups: those who relapsed after complete remission, partial response with persistent disease and refractory.
- •4) Measurable or evaluable disease based on imaging, bone marrow examination.
- •5) Karnofsky = 60% for patients > 16 years of age or Lansky = 60 for patients = 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- •6) A negative serum pregnancy test is required for female subjects of child bearing potential.
- •7) Male subjects and female subjects of child bearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5 of the protocol.
- •8) Lactating females must agree to discontinue nursing before idelalisib is administered
- •9) Adequate bone marrow function defined as:
- •a) For subjects without bone marrow involvement:
- •o Peripheral absolute neutrophil count (ANC) = 1,000/µL, in the absence of growth factors
- •o Platelet count = 100,000/µL (transfusion independent)
- •o Hemoglobin = 8.0 gm/dL (RBC transfusion independent)
- •b) For subjects with bone marrow involvement (requires BM documentation):
- •o Platelet count = 20,000/µL (may receive platelet transfusions or thrombopoietic growth factors)
- •o Hemoglobin = 8.0 gm/dL (may receive RBC transfusions or erythropoietic growth factors)
- •10) Adequate renal function defined as: Estimated creatinine clearance (CrCL) = 70 mL/min/1.73m2 (using the Schwartz formula; =k x L/sCr) ([k is proportionality constant: for children 1-12 years old or adolescent females = 12 years old, k=0.55, and for adolescent males = 12 years old, k=0.70]; L is height in centimeters [cm]; and sCr is serum creatinine [mg/dL])
- •11) Parent/legal guardian must provide written informed consent prior to screening evaluations.
- •Subject will provide assent/consent if applicable.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Subjects previously treated with ICE, with or without an anti-CD20 antibody, or history of hypersensitivity to any components of RICE
- •2) Known active central nervous system or leptomeningeal lymphoma
- •3) Active infection with HIV, HBV, HCV or CMV based on screening serology and PCR results
- •4) Evidence of uncontrolled systemic bacterial, fungal, or viral infection at the time of treatment start (Day 1)
- •5) Ongoing or history of drug-induced pneumonitis
- •6) Ongoing or history of inflammatory bowel disease
- •7) Pregnancy or breastfeeding
- •8) Currently receiving other anti-cancer agents or other investigational drug
- •9) Prior solid organ transplantation
- •10) Prior allogeneic stem cell transplantation within 60 days or active acute graft versus host disease (GVHD) grade 3 or higher (see Appendix 6 for GVHD grading)
- •11) Known hypersensitivity to idelalisib, the metabolites, or formulation excipients.
- •12) Urinary outflow obstruction or inflammation of the urinary bladder (cystitis)
研究者
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