A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
研究概览
简要总结
This is a prospective, open-label investigation to determine whether measurable residual disease (MRD) guided assignment of maintenance therapy is effective in patients with myeloid malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Pre-HCT, patients will undergo usual disease assessments which should include immunophenotypic and/or molecular testing. Based on the results of these tests, patients may or may not be recommended to receive maintenance therapy post-transplant, depending on the presence or absence of a residual malignant clone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at time of transplant.
- •Must have a diagnosis of a myeloid malignancy, myelodysplastic syndrome, myeloproliferative neoplasm (including primary or secondary myelofibrosis), or acute myeloid leukemia or biphenotypic acute leukemia.
- •Pre-transplant disease assessment must include at least one:
- •Immunophenotypic assessment by flow for aberrant blasts
- •NGS to identify persistence of malignant clones using a standard clinically available assay
- •PCR based measurement of prior identified mutations (if applicable)
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- 未提供
研究组 & 干预措施
MRD negative
MRD negative patients assigned to Arm B will receive no intervention.
干预措施: No intervention (Other)
MRD positive
MRD positive patients assigned to Arm A are required to initiate maintenance therapy on this study. Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.
干预措施: Maintenance Therapy (Drug)
研究者
Sameem M. Abedin, MD
Associate Professor
Medical College of Wisconsin