Chemotherapy for Participants With Lymphoma
2020년 7월 23일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
68
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Berlin, 독일, D-12203
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Bremen, 독일, 28205
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Essen, 독일, D-4600
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Hamburg, 독일, 20099
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Kassel, 독일, 34125
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Kiel, 독일, 24116
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Mainz, 독일, 55131
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Moscow, 러시아 연방, 125167
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Saint Petersburg, 러시아 연방, 198255
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Creteil, 프랑스, 94010
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Dijon, 프랑스, 21079
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Lille, 프랑스, 59037
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Nice, 프랑스, 06202
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Nimes, 프랑스, 30029
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Paris, 프랑스, 75475
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Pessac, 프랑스, 33604
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Pierre Benite, 프랑스, 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, 프랑스, 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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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
다른 이름들:
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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]
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 2월 1일
기본 완료 (실제)
2009년 11월 1일
연구 완료 (실제)
2012년 11월 1일
연구 등록 날짜
최초 제출
2007년 2월 16일
QC 기준을 충족하는 최초 제출
2007년 2월 16일
처음 게시됨 (추정)
2007년 2월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 8월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 7월 23일
마지막으로 확인됨
2020년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 9819 (기타 식별자: Fred Hutch/University of Washington Cancer Consortium)
- H6Q-MC-S013 (기타 식별자: Eli Lilly and Company)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
림프종, 대세포, 미만성에 대한 임상 시험
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SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.모병미만성 거대 B세포 림프종 | 재발성 미만성 대형 B세포 림프종 | 난치성 미만성 대형 B세포 림프종 | 원발성 종격동(흉선) 대형 B세포 림프종 | 등급 3b 여포성 림프종 | 변형된 여포 림프를 Diff 대형 B-세포 림프종으로 | 변형된 마그 존 림프를 Diff Large B-Cell Lymphoma로미국