EUCTR2008-003540-11-BE进行中（未招募）不适用
Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial. - HOVON 96 GVHD
HOVON Foundation0 个研究点目标入组 500 人开始时间: 2010年3月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •- Age 18-70 inclusive
- •- AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
- •- Planned allogeneic stem cell transplantation
- •- Related or unrelated donor with a 8/8 genotypical HLA match (HLA A, B, C, DRB1)
- •- WHO performance status 0-2
- •- Written Informed Consent
- •- Negative pregnancy test (if applicable)
- •- Patients who are willing and capable to use adequate contraception during Myfortic treatment (all pre-menopausal women)
- •Are the trial subjects under 18? no
- •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 490
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Renal dysfunction (serum creatinine > 150 mmol/L or clearance < 50 ml/min)
- •- Patients with active, uncontrolled infection
- •- Cord Blood transplantation
- •- Patients receiving ATG pre-transplantation as part of the conditioning regimen
- •- Patients with progressive disease in case of MM, CLL, NHL, HL
- •- Patients with > 5% marrow blasts in case of AML, ALL, CML
- •- Patients with EMD in case of AML, ALL, CML
研究者
相似试验
进行中（未招募）
1 期
Preventie van ernstige Graft versus Host ziekte na allogene stamcel transplantatie gegeven als immuuntherapie voor patienten met een hematologische ziekte. Een gerandomiseerde fase III studie (HOVON 96 GVHD).Graft versus Host DiseaseMedDRA version: 20.0Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 100000004870EUCTR2008-003540-11-NLHOVON Foundation500
已完成
3 期
Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial.Graft versus Host Disease10018849NL-OMON47822HOVO497
招募中
不适用
Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial.Randomization 1: Patients planned to undergo an allogeneic SCT formalignant hematological disorders and with a related or unrelated 8/8 HLA matched donor.NL-OMON28315Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl500
进行中（未招募）
不适用
Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.A prospective double-blind placebo-controlled randomized phase III trialGraft Versus Host DiseaseMedDRA version: 18.0Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 18.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 10021428 - Immune system disordersEUCTR2011-003237-33-NLHOVON Foundation200
招募中
不适用
Prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors with C3 monitoring of cyclosporine: a multicenter prospective study.Hematological malignancyJPRN-UMIN000002817Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science70