NCT01613300已完成2 期
Ofatumumab as Part of the Reduced Intensity Conditioning Regimen (RIC) for Patients With High Risk B Non Hodgkin's Lymphoma Undergoing Allogeneic Hematopoietic Cell Transplantation
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea10 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年4月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 10
- 主要终点
- Rate of acute grade II-IV graft-versus-host disease at 1 year
研究概览
简要总结
The aim of this study is rate of acute graft-versus-host disease II-IV measured at day +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant
详细描述
In addition to above:
- Rate of progression-free survival (PFS) at 12, 24, 36 and 60 months post-transplant defined as the time between the infusion of progenitors and the disease progression or death. Patients alive or in complete remission will be censored at the time of last follow up
- Transplant-related mortality (TRM) at 12, 24, 36 and 60 months after transplantation, defined as any death not caused directly by lymphoma (any death caused by complications related to transplantation).
- Overall survival (OS) defined as the time between infusion of progenitors and the patient's death from any cause. Alive Patients will be censored at the time of last follow-up
- Incidence of chronic graft versus host disease (GVHD) wide at 1 and 5 years according to conventional criteria (Atkinson et al. 1989) and Filipovich et al. (BBMT, 2005).
- Rate of event-free survival (DFS) defined as time interval between diagnosis of lymphoma and lymphoma progression or relapse or death if the above does not occur.
- Successful graft implantation: is defined as:
- º: three consecutive days with absolute neutrophil count greater than 0.5 * 109 / L
- ° thrombocythemia exceeds 20 * 109 / L.
- Reconstitution of the immune system: lymphocyte count populations CD20, CD3, CD4 and CD8 and immunoglobulinemia serum (days +100, 180, 360, 18 months and 24 months).
- intercurrent infections. All sorts of infections (viral, fungal and bacterial)will be recorded
- Safety assessment by the standards of Common Terminology Criteria for adverse events v. 4.0
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have given their informed consent before any study-specific procedures
- •Histopathological diagnostic of NHL cell B CD 20 + B of different histologic subtypes:
- •High risk CD +20 Lymphoma having at least one of the following characteristics:
- •Less than a partial remission after two courses of treatment
- •Relapse after autologous peripheral blood stem cell (PBSCT)
- •Evidence of measurable disease (With CT and PET or PET / CT) three months after PBSCT
- •Hematopoietic precursors improper count in patients with relapsed or partial remission after two treatment lines that prevent the realization of a PBSCT.
- •Patients after first relapse in RP after two lines of treatment in whom the probability of freedom from progression per year is very low due to risk factors such as: first CR less than 12 months after PBSCT low SLP, etc..
- •Age between 18 and 65 years
- •ECOG between 0 to 1 (Appendix III).
- •Subjects who are HBgAG negative, anti-HBc positive and HBV DNA negative may be include in the study but must undergo HBV DNA monitoring
- •Adequate lung Function
- •Cardiac ejection greater than 40% as measured by scintigraphy or echocardiography.
- •Adequate renal and hepatic function defined by the following biochemical parameters
- •The disease status prior to transplantation had to be in place in accordance with the criteria of Revised Response Criteria for Malignant Lymphoma, Cheson
- •CT and PET or PET / CT.
- •Availability of a histocompatible donor (9 to 10/10 loci) family or unrelated
- •Adults with ability to procreate must commit to use an effective method of birth control during the study treatment and at least 6 months.
排除标准
- •Refractory disease at the time of transplantation
- •Progressive disease at the time of transplantation.
- •Lymphoma associated with infection with human immunodeficiency virus (HIV).
- •Test positive for HIV.
- •Presence of anti-murine antibodies (HAMA) or (HACA).
- •Treatment with any marketed or experimental drug administered not in a period between 5 terminal half-lives of clearance of therapy or 4 weeks before enrollment
- •Participation in another interventional clinical trial.
- •Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy. This is generally required and may be excluded as applicable.
- •Hepatitis B positive serology
- •Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.
- •Positive serology for hepatitis C (HC) defined as a positive test for HCAb.
- •Active liver or biliary disease (with exception of Gilbert's disease, cholelithiasis, metastases).
- •Other past or current malignancy.
- •Chronic infectious disease that requires ongoing treatment with systemic antibiotics, antifungal or antiviral drugs
- •History of cerebrovascular disease active in the last 6 months or event with significant symptoms or sequelae.
- •Clinically significant heart disease, such as unstable angina, acute myocardial infarction in the six months prior to inclusion, congestive heart failure (grades III-IV NYHA) and arrhythmia unless it is controlled by treatment, except for premature or disorders Mild driving.
- •Concurrent medical disorder, uncontrolled and important, such as kidney disease, liver, digestive, endocrine, pulmonary, neurological, brain, psychiatric, or which in the opinion of the investigator may represent a risk to the patient
- •Pregnancy or breastfeeding
- •Women of childbearing potential, including those whose last menstrual period was one year prior to screening.
- •Men unable or unwilling to use contraception
- •Patients with hypersensitivity to fludarabine, melphalan, thiotepa, tacrolimus, sirolimus and / or any excipients.
研究组 & 干预措施
Ofatumumab
Experimental
Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Rate of acute grade II-IV graft-versus-host disease at 1 year
时间窗: 5 years follow-up
According to conventional criteria. This endpoint will be descriptively reported. Confidence intervals (95% bounds) will be provided. The rate will be analyzed in all patients enrolled at the clinical trial and that no major violation has been produced.
次要结局
- To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary(5 years follow up)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory LeukemiaLeukemia, Acute LymphoblasticMixed-Lineage Acute LeukemiasAcute Myeloid LeukemiaNCT02799147St. Petersburg State Pavlov Medical University27
Unknown
4 期
Study on Effectiveness of 2-dose Live Attenuated Varicella VaccineVaricellaNCT02146469Shanghai Municipal Center for Disease Control and Prevention1,200
已完成
2 期
Intensive Consolidation and Stem Cell Mobilization Therapy Followed by Autologous Stem Cell Transplantation in High-risk Patients With Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large Cell Lymphoma Relapsed/RefractoryNCT01555541C. Babis Andreadis19
已完成
1 期
Ofatumumab as Primary Therapy of Chronic Graft Versus Host DiseaseChronic Graft Versus Host DiseaseNCT01680965H. Lee Moffitt Cancer Center and Research Institute44
已完成
2 期
Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell TransplantationHematopoietic Stem Cell TransplantationGraft Versus Host DiseaseNCT00948727Assistance Publique - Hôpitaux de Paris39