EUCTR2012-002879-34-NL进行中(未招募)1 期
Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation - MiHA-loaded DC vaccination after allogeneic SCT
Radboud University Nijmegen Medical Centre0 个研究点开始时间: 2012年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
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
- •Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL, MM or malignant NHL, who underwent HLA-matched allo-SCT
- •Patients positive for HLA-A2, HLA-A24, HLA-B7 and/or HLA-B44
- •Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor
- •Patients >18 and <65 years of age
- •WHO performance 0-2
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Life expectancy < 3 months
- •Severe neurological or psychiatric disease
- •Progressive disease needing cytoreductive therapy
- •HIV positivity
- •Patients with acute GVHD grade 3 or 4
- •Patients with extensive chronic GVHD
- •Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
- •Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
- •Severe pulmonary dysfunction (CTCAE III-IV)
- •Severe renal dysfunction (serum creatinine > 3 times normal level)
- •Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level)
- •Patients with known allergy to shell fish
研究者
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Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I study)blood cell cancerhematological malignancies10027656NL-OMON40014niversitair Medisch Centrum Sint Radboud10
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MiHA-DC vaccinatie na allogene stamceltransplantatie.Patients with AML, MDS, ALL, CML (accelerated or blast phase), CLL, MM or malignant NHL, who underwent HLA-matched allo-SCT.NL-OMON29214Radboud University Nijmegen Medical Centre
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Vaccination with human minor H antigen (HA-1) peptide after allogeneic stem cell transplantatioISRCTN80896844eiden University Medical Centre (LUMC) (Netherlands)24
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Predetermined Minor Histocompatibility Antigen-based Therapeutic or Prophylactic Peptide Vaccinations for Patients with Recurred Malignancies or Patients with High-Risk Malignancies Follwoing Allogeneic Hematopoietic Cell Transplantation.(1) Therapeutic vaccine: Any hematological malignancies recurred after allogineic hematopoietic transplanation as follows (RAEB, CMML, AML, ALL, CML, Multiple Myeloma, NHL). (2) Prophylactic vaccine: Hematological malignancies with high risk of relapse after allogineic hematopoietic transplanation as follows (RAEB, CMML, AML in >=3CR/non-CR or any AML with M0/M6/M7 FAB type, ALL in >=2CR/non-CR, CML in >=2CP or >=AP, Multiple Myeloma in PD, NHL in non-CR).JPRN-UMIN000000872Aichi Cancer Center Research Institute12
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Donor Dendritische Cellen vaccinatie bij hematologische maligne aandoeningeEUCTR2012-002435-28-NLniversity Medical Center Utrecht
