Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,365
- 试验地点
- 5
- 主要终点
- number of patients who proceed to transplant
研究概览
简要总结
The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.
详细描述
Additional Arms have been added for MSK patients only. Patients with MDS and MPN Patients with Post-transplant Relapse of Acute Leukemia, MDS or MPN
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A
- •Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines):
- •Clinically significant cytopenia of at least 2 cell lines affected; Hgb<10,
- •Platelet<100,000, absolute neutrophil count<1000
- •Bone marrow blasts >5% and any level of circulating blasts
- •Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial.
- •IPSS Intermediate-1 and higher
- •IPSS-R intermediate and higher
- •All cases of therapy related MDS with excess blasts
- •In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermediate 1 and higher. For patients with post-PV and post-ET myelofibrosis, any patient with MYSEC-PM Intermediate-1 risk or higher is eligible.
- •Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.
- •Patients 18 years of age or older and 80 years of age or younger
- •For the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc.
- •Patients previously enrolled in Arm A or Arm B who experience post-transplant relapse are also eligible for enrollment onto Arm C
排除标准
- •Patients with polycythemia vera (PV) and essential thrombocytosis (ET)
研究组 & 干预措施
Patients with Acute Leukemia (Arm A)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
干预措施: assessments (Other)
Patients with MDS and MPN (Arm B)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
干预措施: assessments (Other)
Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
干预措施: assessments (Other)
结局指标
主要结局
number of patients who proceed to transplant
时间窗: 3 years
determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.
次要结局
未报告次要终点