Chemotherapy for Participants With Lymphoma
2020年7月23日 更新者：Eli Lilly and Company
An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma
The primary purpose of this study is to help answer the following research questions:
- To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
- To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
- To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
- To look at the level of enzastaurin in the body and how long it remains.
調査の概要
研究の種類
介入
入学 (実際)
68
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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Berlin、ドイツ、D-12203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bremen、ドイツ、28205
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Essen、ドイツ、D-4600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamburg、ドイツ、20099
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kassel、ドイツ、34125
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kiel、ドイツ、24116
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mainz、ドイツ、55131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Creteil、フランス、94010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dijon、フランス、21079
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lille、フランス、59037
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Nice、フランス、06202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nimes、フランス、30029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris、フランス、75475
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pessac、フランス、33604
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pierre Benite、フランス、69495
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rouen、フランス、76038
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Moscow、ロシア連邦、125167
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Petersburg、ロシア連邦、198255
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
60年歳以上 (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:
- Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent lymphoma
- Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line.
- Measurable disease (lymph node greater than 1.5 cm)
- Adequate organ function
- Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)
Exclusion Criteria:
- Prior Allogeneic transplantation
- More than 2 prior anticancer treatment regimens
- Pregnant or breastfeeding
- Human-immunodeficiency-virus (HIV)associated lymphomas
- Brain metastases
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：Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
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1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
他の名前：
1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
他の名前：
375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
100 mg/m², IV, once every two weeks, four to eight 2 week cycles
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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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Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
時間枠：First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year
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PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times.
The PFS rate at 1 year was determined using Kaplan-Meier estimates.
For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment.
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First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year
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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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Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)
時間枠：Baseline to Measured Progressive Disease or Death from Any Cause at End of 4 and 8 Cycles
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Assessment of response was based on the International Workshop to Standardize Response criteria for lymphoma (Cheson et al. 1999).
CR is the complete disappearance of all detectable clinical and radiologic evidence of disease; all lymph nodes and nodal masses must have regressed to normal size (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy).CRu is as CR but with 1 or more of the following features: A residual lymph node mass >1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD) and/or indeterminate bone marrow with normalization of all biologic abnormalities.
PR is regression of more than 50% (SPD) of all measurable lesions, disappearance of nonmeasurable lesions and no new lesion.
For each response category the number of participants with this response will be divided by the total number of participants treated to achieve the response rate.
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Baseline to Measured Progressive Disease or Death from Any Cause at End of 4 and 8 Cycles
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Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment
時間枠：First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 2 Years, 4 Years
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PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). PFS rate was defined as the rate of PFS at 2 year from the date of first dose of study drug and was determined using the distribution of overall PFS times. PFS rate was defined as the rate of PFS at 4 year from the date of first dose of study drug and was determined using the distribution of overall PFS times. For participants not known to have died as of the data cut-off date and who did not have PD, PFS was censored at the date of the last progression-free disease assessment. |
First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 2 Years, 4 Years
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Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years
時間枠：First Dose of Study Drug to Death from Any Cause at 1 Year, 2 Years and 4 Years
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Overall survival was defined as the time from the date of first dose of study drug to the date of death from any cause.
For participants who were not still alive at the time of analysis, survival time was censored at the last contact date.
For participants not known to have died as of the cut-off date for analysis,OS was censored at the last contact date for participants in post-discontinuation.
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First Dose of Study Drug to Death from Any Cause at 1 Year, 2 Years and 4 Years
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Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years
時間枠：First Dose of Study Drug to Measured PD, or Start of New Lymphoma Treatment or Death from Any Cause at 1 Year, 2 Years and 4 Years
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Event-free survival time was defined as the time from the date of first dose of study drug to the first date of measured PD,or start of a new treatment for the lymphoma, or death from any cause.
For participants not known to have events as of the data cut-off date, EFS was censored at the date of the last tumor assessment.
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First Dose of Study Drug to Measured PD, or Start of New Lymphoma Treatment or Death from Any Cause at 1 Year, 2 Years and 4 Years
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Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)
時間枠：Baseline, Cycles 1-4, End of Study
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PFS based on DLBCL molecular subtypes (GCB vs non-GCB) were determined.
The molecular characterization of germinal center B-cells (GCBs) vs. non-GCBs was analyzed as separate combination immunohistochemistry (IHC) markers based on the Hans algorithms.
Molecular subtype was included as class effect in the analytical models, adjusting for International Prognostic Index (IPI) score.
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Baseline, Cycles 1-4, End of Study
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PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin)
時間枠：Baseline, Cycles 1-4, End of Study
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Reported PFS was based on PKCB2 protein expression assessed by immunohistochemistry (scored in 10% increments for percent of tumor cells).
Protein expression levels was grouped into high and low in association with the clinical endpoints.
Grouping was based on 1) a pre-specified threshold provided by the pathologist at Cleveland Clinic for the diffuse large B-cell lymphoma (DLBCL)-prognostic markers, and 2) a median cut-point for the enzastaurin-specific markers.
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Baseline, Cycles 1-4, End of Study
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Pharmacokinetics (PK): Maximum Observed Drug Concentration During a Dosing Interval at Steady State(Cmax,ss) for Total Analyte [Characterization of Pharmacokinetics of Enzastaurin and Its Metabolites]
時間枠：Day 2 of Cycle 2: Predose;1-2 Hours(H);3-4 h;5-6 h;7-8 H Postdose
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Cmax,ss is defined as the maximum observed drug concentration during a dosing interval at steady state.
Non-Compartmental Pharmacokinetic Parameters for Total Analyte (Enzastaurin + LSN326020).
LSN326020 is Enzastaurin's major active metabolite.
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Day 2 of Cycle 2: Predose;1-2 Hours(H);3-4 h;5-6 h;7-8 H Postdose
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PK: Area Under the Concentration vs. Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Total Analyte
時間枠：Day 2 of Cycle 2: Predose;1-2 hours(h);3-4 h;5-6 h;7-8 h Postdose
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AUCτ,ss is defined as the area under the concentration versus time curve during 1 dosing interval at steady state.
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Day 2 of Cycle 2: Predose;1-2 hours(h);3-4 h;5-6 h;7-8 h Postdose
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Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years
時間枠：First Dose of Study Drug to Relapse after CR or CRu or Death from any Cause at 1 Year, 2 Years and 4 Years
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DFS was calculated as the duration from date of first dose of study drug to the date of first relapse event after CR or CRu or death from any cause.
Participants who have not experienced an event at the time of analysis were censored at the most recent date of disease assessment.
Events are relapse after a CR or CRu.
Related death or death from unknown cause was considered as an event.
Unrelated death was not considered as an event and the participant was censored at the time of death for this analysis.
Unrelated death was defined as death from a cause not related to the lymphoma, any examination done for the lymphoma, or any treatment of the lymphoma.
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First Dose of Study Drug to Relapse after CR or CRu or Death from any Cause at 1 Year, 2 Years and 4 Years
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Duration of Tumor Response (DOR)
時間枠：Time from Observed CR and CRu or PR (Up to 4 Years)
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Duration of tumor response was defined as the time from the date when the measurement criteria were met for CR and CRu or PR (whichever status was recorded first) until the date of first observation of objective disease progression.
For responding patients who died without objective PD (including death from study disease), duration of response was censored at the date of the last objective progression-free disease assessment.
For responding patients not known to have died as of the data cut-off date and who do not have objective PD, duration of response was censored at the date of the last objective progression-free disease assessment.
For responding patients who received subsequent systemic anticancer therapy (after discontinuation from the study chemotherapy) prior to objectively determined disease progression, duration of response was censored at the date of the last objective progression-free disease assessment prior to post-discontinuation therapy.
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Time from Observed CR and CRu or PR (Up to 4 Years)
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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
2007年2月1日
一次修了 (実際)
2009年11月1日
研究の完了 (実際)
2012年11月1日
試験登録日
最初に提出
2007年2月16日
QC基準を満たした最初の提出物
2007年2月16日
最初の投稿 (見積もり)
2007年2月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年8月6日
QC基準を満たした最後の更新が送信されました
2020年7月23日
最終確認日
2020年7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
- 9819 (Fred Hutch/University of Washington Cancer Consortium)
- H6Q-MC-S013 (その他の識別子：Eli Lilly and Company)
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。