EUCTR2008-005862-30-DE进行中（未招募）不适用
Pre-emptive therapy of acute graft versus host disease according to specific proteomic patterns after allogeneic hematopoietic stem cell transplantation. - PRE-GvHD
Medizinische Hochschule Hannover0 个研究点开始时间: 2008年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- •Written informed consent
- •All patients = 18 years on day +7 (+/- 3) after 1st allo-HSCT
- •Patients transplanted for: acute myeloid or lymphoid leukemia in CR (<5% leukemic blast cells in the bone marrow) or PR (<20% leukemic blast cells in the bone marrow); myelodysplastic and/or myeloproliferative syndromes: untreated, CR, PR; lymphomas: PR; chronic myeloid leukemia: CP; chronic lymphatic leukemia: CR, PR; multiple myeloma: CR, PR; severe aplastic anemia at the time of allogeneic HSCT
- •aGvHD prophylaxis with any combination of the following: e.g. cyclosporin A (CsA), methotrexate (MTX), mycophenolic acid (MMF), tacrolimus, sirolimus, everolimus and others with or with-out immunosuppressive antibodies (e.g. anti-thymocyte globulin (ATG))
- •Woman of childbearing potential must have a negative pregnancy test prior to HSCT
- •Sufficient contraceptive methods for men and women of reproductive age at the beginning of the study and during the study and consent of the patient to used a sufficient contraceptive method within 6 months after the end of the study. Permitted double contraceptive methods are implants, injection preparation, intrauterine devices, portal cap, sterilization, hysterectomy, condoms, spermicide, vasectomy and/or sexual abstinence.
- •Prior to randomization:
- •Positivity of aGvHD-specific proteomic pattern
- •(Patients enrolled, who can not be randomized, will be followed-up in the observational group).
- •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 234
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Patients after = 2nd allo-HSCT
- •Patients transplanted in relapse of their underlying disease (AML, ALL: =20% leukemic blast cells in the bone marrow)
- •Transplantation with CD34+-enriched or ex vivo T-cell-depleted stem cells, transplantation from syngeneic or haploidentical or cord blood donors
- •Steroids as part of the acute GvHD prophylaxis
- •Pregnant or nursing women
- •Participation in an other therapeutic study within 30 days before and during this study
- •Prior to randomization:
- •Patients with acute GvHD grade II to IV
- •Acute renal failure (= 2x upper normal boundary of serum creatinine)
- •Serious, life-threatening infection at the time of sampling for aGvHD proteomic pattern
- •Relapse or progression of underlying disease
- •(Patients enrolled, who cannot be randomized, will be followed-up in the observational group).
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