Individualized AML Treatment
Feasibility Study of Individualized Treatment Recommendations for Acute Myeloid Leukemia Based on High Throughput Screening and Genomics Data
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Pamela Becker, MD
- 電話番号:626-218-2405
- メール:pbecker@coh.org
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- 募集
- City of Hope Medical Center
-
コンタクト:
- Pamela Becker, MD
- 電話番号:626-218-2405
- メール:pbecker@coh.org
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
R/R AML
Adults with relapsed/refractory acute myeloid leukemia
|
This is a non-interventional study
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility - Obtaining HopeSeq and CDST
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants with successful CDST HTS reports
時間枠: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
時間枠:Up to 1 year
|
Successful initiation of treatment
|
Up to 1 year
|
|
Average time to successful initiation of treatment
時間枠:Up to 1 year
|
Time from sample acquisition to successful initiation of treatment
|
Up to 1 year
|
|
Degree of cytoreduction
時間枠: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
時間枠: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)
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Pamela Becker, MD、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 24673
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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