ISRCTN53325562已完成2 期
A prospective randomised, phase II study to investigate the efficacy and safety of pre-emptive cytomegalovirus (CMV) adoptive cellular therapy in patients receiving allogeneic haematopoietic stem cell transplant from an unrelated donor
Cell Medica Ltd (UK)0 个研究点目标入组 36 人开始时间: 2008年8月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 22/02/2011:
- •1. Age 16 years or older
- •2. CMV-seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) HSCT recipient with CMV-seropositive unrelated donor
- •3. Patient informed consent
- •4. Prepared to undergo additional study procedures as per study schedule
- •5. Patient has undergone counselling about risk
- •6. Donor engraftment (neutrophils > 0.5x10^9/l) (to be assessed prior to CMV-specific T-cell infusion)
- •7. Single positive CMV PCR result (and to be assessed prior to CMV-specific T-cell infusion)
- •8. The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure.
- •9. Donor must have met requirements of EU Tissue and Cells Directive (2004/23/EC) as amended and the UK statutory instruments pursuant therein.
- •10. Healthy, CMV-seropositive donor - having passed medical for stem cell donation
- •11. Subject and donor must have negative serology for HIV, hepatitis B and C, syphilis
- •12. HLA type A*0101, A*0201, A*2402, B*0702, B*0801, B*3501
- •13. Donor informed consent for stem cell mobilisation leucapheresis and storage
- •Previous inclusion criteria:
- •1. Both males and females, aged 16 years or over
- •2. Patients considered fit for allogeneic peripheral blood stem cell transplant
- •3. Sibling or matched unrelated allogeneic peripheral blood stem cell transplant (PBSCT) using alemtuzemab
- •4. CMV-seropositive patient and donor
- •5. Patients and donor sharing at least one of the following HLA alleles:- HLA-A*0101, HLA*0201, HLA-A*1101, HLA-A*2402, HLA-B*0702, HLA-B*0801, HLA-B*3502
- •6. Patient willing and able to give consent and comply with trial protocol
排除标准
- •Current exclusion criteria as of 22/02/2011:
- •1. Pregnant or lactating women
- •2. Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
- •3. HIV infection
- •4. Active acute GVHD > Grade I (to be assessed prior to CMV-specific T-cell infusion)
- •5. Concurrent use of systemic corticosteroids (to be assessed prior to CMV-specific T-cell infusion)
- •6. Organ dysfunction (to be assessed prior to CMV-specific T-cell infusion ) as measured by:
- •6.1. Creatinine > 200 uM/l
- •6.2.Bilirubin > 50 uM/l
- •6.3.Alanine transferase > 3x upper limit of normal
- •7. Donor pregnant or lactating
- •8. Donor platelets < 50x10^9/l
- •Previous exclusion criteria:
- •1. Donors whose stem cells have already been collected and cryopreserved prior to transplant
- •2. Patients whose donor stem cell harvests are <4.0 x 10^6 CD34 cells/kg will not proceed with the study
- •3. Bone marrow transplants
研究者
相似试验
已完成
不适用
A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteersBacterial infections10004018NL-OMON43462Wockhardt Bio AG55
进行中（未招募）
1 期
An open-label, randomised, Phase II study to investigate the efficacy andsafety of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells(ALECSAT) treatment as an add-on therapy to radiotherapy andtemozolomide (standard of care) in patients with newly diagnosedglioblastoma (malignant primary brain tumor)Glioblastoma multiformeEUCTR2015-004058-17-SECytoVac A/S60
进行中（未招募）
1 期
Clinical study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiencyEUCTR2011-004154-25-ITBiotest AG20
进行中（未招募）
1 期
AcromegaliaAcromegalyEUCTR2013-003183-31-ROITALFARMACO S.p.A.40
进行中（未招募）
1 期
AcromegaliaAcromegalyEUCTR2013-003183-31-PLITALFARMACO S.p.A.40