Individualized AML Treatment
Feasibility Study of Individualized Treatment Recommendations for Acute Myeloid Leukemia Based on High Throughput Screening and Genomics Data
研究概览
详细说明
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Pamela Becker, MD
- 电话号码:626-218-2405
- 邮箱:pbecker@coh.org
学习地点
-
-
California
-
Duarte、California、美国、91010
- 招聘中
- City of Hope Medical Center
-
接触:
- Pamela Becker, MD
- 电话号码:626-218-2405
- 邮箱:pbecker@coh.org
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Documented informed consent of the participant and/or legally authorized representative.
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- Age: ≥ 18 years
- ECOG ≤ 3 (Appendix A)
- Patients with histologically confirmed AML according to ICC or WHO criteria, and
- Refractory/relapsed (R/R) to prior treatment with one or more regimens if adverse risk or two or more regimens if favorable/intermediate risk (Appendix B)
- Sufficient bone marrow and/or peripheral blood sample (archival or fresh) to run the high throughput screening (HTS; Estimate sufficient if circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts.) Otherwise,
- Sufficient cells flushed from bone marrow biopsy, if bone marrow is not aspirable, OR
- Extramedullary disease, if it is possible to obtain a fluid or biopsy sample from that location
- Expected survival is greater than 100 days.
- Fully recovered from the acute toxic effects (except alopecia) to ≤ Grade 1 to prior anti-cancer therapy
Exclusion Criteria:
- Treatment with any chemotherapeutic agent necessary to control AML burden is permitted between day -18 and -1.
- Must not have received or planning to receive live vaccine while being on study
- Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Active central nervous system (CNS) disease (OK if treated and responding)
- Active graft vs host disease (GVHD)
- Unstable cardiac disease as defined by one of the following:
- Cardiac events such as myocardial infarction (MI) within the past 6 months
- Uncontrolled atrial fibrillation or hypertension
- Clinically significant uncontrolled illness
- Uncontrolled active infection
- Females only: Pregnant or breastfeeding
- Any other condition or active malignancy that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
R/R AML
Adults with relapsed/refractory acute myeloid leukemia
|
This is a non-interventional study
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility - Obtaining HopeSeq and CDST
大体时间:Up to 18 days after sample acquisition
|
Success in obtaining HopeSeq Heme Comprehensive (HopeSeq) and Cancer Drug Sensitivity Test Diagnostic (CDST) High Throughput Screen (HTS) reports and interpretation of results by the Functional Molecular Tumor Board (FMTB) Success of performing HOPESEQ and CDST HTS and obtaining an individualized treatment recommendation from the FMTB based on multiomic data within 18 days from sample acquisition. |
Up to 18 days after sample acquisition
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants with successful CDST HTS reports
大体时间:Up to 18 days of sample acquisition
|
Samples received with sufficient cell numbers and viability to perform CDST HTS Success of performing HOPESEQ and CDST HTS and obtaining an individualized treatment recommendation from the FMTB based on multiomic data within 18 days from sample acquisition in at least 70% of participants. |
Up to 18 days of sample acquisition
|
|
Proportion of patients with successful initiation of treatment
大体时间:Up to 1 year
|
Successful initiation of treatment
|
Up to 1 year
|
|
Average time to successful initiation of treatment
大体时间:Up to 1 year
|
Time from sample acquisition to successful initiation of treatment
|
Up to 1 year
|
|
Degree of cytoreduction
大体时间:Up to 2-5 weeks after treatment
|
Bone marrow percent cellularity and percent leukemia by morphology and flow cytometry compared to pre-treatment level
|
Up to 2-5 weeks after treatment
|
|
Preliminary estimate of remission
大体时间:Up to 1 year
|
Response, duration of remission, time to next treatment as compared to prior interval with most recent treatment, ability to proceed to transplant Using AML Risk Stratification Criteria by Genetics at Initial Diagnosis from Dohner et al. (2022) |
Up to 1 year
|
|
Overall survival (OS) and progression-free survival (PFS)
大体时间:Up to 1 year
|
Day 1 to date of death (OS) or relapse/death (PFS) or last follow up, whichever comes first Overall survival (OS) and progression-free survival (PFS) will be assessed using the Kaplan-Meier product-limit method, with the median and 95% CI estimated. |
Up to 1 year
|
合作者和调查者
调查人员
- 首席研究员:Pamela Becker, MD、City of Hope Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.