Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
2018年11月1日 更新者：William Blum、Emory University
First-Line Dasatinib or Nilotinib Followed by Response Guided Switch to Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature blood cells) (chronic phase).
Dasatinib, nilotinib, and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
調査の概要
詳細な説明
PRIMARY OBJECTIVE:
I. To assess incidence of major molecular response (MMR) at 12 months.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 12 and 24 months.
II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12 and 24 months.
III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.
IV. To assess safety.
V. To assess patient reported outcomes (PRO).
TERTIARY OBJECTIVES:
I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on diagnostic bone marrow.
II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine kinase inhibitors (TKIs) discontinuation trials.
OUTLINE:
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
After completion of study treatment, patients are followed up at 2 weeks and then up to 60 months.
研究の種類
介入
入学 (実際)
7
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University/Winship Cancer Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
17年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days prior to enrollment)
- Clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications
- Able to give written informed consent and comply with all study visits and procedures
Exclusion Criteria:
- Chronic myeloid leukemia (CML) in AP or BP
- Unable to receive TKI for insurance reasons (uninsurable)
- Refuse or unable to perform telephone or video conferences with research coordinator
- Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
- Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Treatment-dasatinib, nilotinib, imatinib
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist.
Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
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口頭で与えられる
他の名前：
口頭で与えられる
他の名前：
Given orally
他の名前：
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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 |
|---|---|---|
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The Proportion of Subjects Who Achieve Major Molecular Response (MMR)
時間枠：At 12 months
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Response will be measured by a decrease in fusion transcript or protein resulting from the 9;22 chromosomal translocation responsible for formation of the Philadelphia Chromosome (BCR-ABL1) levels on a logarithmic scale.
A 1 log reduction is a drop to below 10%, while a major molecular response (MMR) is defined as a 3 log reduction (0.1%).
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At 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Accelerated Phase (AP) or Blast Phase (BP) Free Survival
時間枠：The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months
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Survival will be defined as the time from CML diagnosis to the time of transformation to accelerated phase (AP) or blast phase (BP).
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The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months
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Change in Patient Reported Outcomes (PRO) Score Extracted From the MD Anderson Symptom Inventory-Chronic Myelogenous Leukemia (CML)
時間枠：Baseline to up to 12 months
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The patient reported outcomes (PRO) score extracted from the MD Anderson Symptom Inventory (MDASI)-Chronic Myelogenous Leukemia (CML) will be determined and intra and inter subject changes will be compared.
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Baseline to up to 12 months
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Duration of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria
時間枠：Up to 30 days after the end-of-treatment
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Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented.
Exposure to drug over time will also be summarized.
The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.
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Up to 30 days after the end-of-treatment
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Frequency of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) Criteria
時間枠：Up to 30 days after the end-of-treatment
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Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented.
Exposure to drug over time will also be summarized.
The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.
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Up to 30 days after the end-of-treatment
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Progression Free Survival (PFS)
時間枠：The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months
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Progression free survival (PFS) will be defined as the time from CML diagnosis to the time of loss of major molecular response (MMR) or loss of hematologic response.
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The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months
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Severity of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria
時間枠：Up to 30 days after the end-of-treatment
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Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented.
Exposure to drug over time will also be summarized.
The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.
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Up to 30 days after the end-of-treatment
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The Number of Subjects With Breakpoint Cluster Region-abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) Transcript Levels ≤ Deep Molecular Responses (MR⁴)
時間枠：Up to 24 months
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Descriptive statistics will summarize the changes in breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) testing over time will be presented.
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Up to 24 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年10月1日
一次修了 (実際)
2018年7月1日
研究の完了 (実際)
2018年7月1日
試験登録日
最初に提出
2016年3月10日
QC基準を満たした最初の提出物
2016年3月10日
最初の投稿 (見積もり)
2016年3月15日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月2日
QC基準を満たした最後の更新が送信されました
2018年11月1日
最終確認日
2018年11月1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
- IRB00087045
- NCI-2016-00162 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- Winship3143-16 (その他の識別子：Emory University/Winship Cancer Institute)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
メシル酸イマチニブの臨床試験
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The First Hospital of Jilin Universityまだ募集していません敗血症誘発性凝固障害（sic）