- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02018523
Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer
A Pilot Study of Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer After First-line Chemotherapy
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed stage IIIB or stage IV NSCLC with measurable disease at initial presentation prior to chemotherapy. See Section 8.4.1 for measurable disease parameters.
- Patients must have had a complete response (CR), partial response (PR) or stable disease (SD) after 4-6 cycles of first-line chemotherapy. Tumor response will be assessed by RECIST criteria version 1.1.
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, or radiotherapy before entering this study.
- Myelosuppressive chemotherapy: At least 21 days elapsed from end of treatment before registration (42 days if prior nitrosourea).
- Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor.
- Other: For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.
- XRT: > or = to 2 weeks for local palliative XRT (small port); 3 months must have elapsed if 50% radiation of pelvis; 6 weeks must have elapsed if other substantial bone marrow radiation.
- Patients must be > or = 18 years of age.
- ECOG performance status < or = to 1 (Karnofsky > 70%).
Organ Functions: Patients must have normal organ and marrow function as defined below within 28 days of registration:
- Leukocytes > or = 3,000/uL
- Absolute neutrophil count > or = 1,500/uL
- Hemoglobin > or = 8 g/dL
- Platelets > or = 100,000/uL
- Total bilirubin 1.5X institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) 1.5X institutional ULN
- Creatinine clearance > or = 60 mL/min/1.73 m2 for patients with creatinine levels > institutional normal
- All study participants must be willing and agree to be registered into the mandatory REVLIMID REMS program, and be willing and able to comply with the requirements of REVLIMID REM. REVLIMID REMS registration does not need to be complete to determine study eligibility.
Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days before registration. Treating investigator must affirm intention to perform another serum or urine UPT 24 hours before initiating lenalidomide treatment.
*FCBP: A female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- All patients must be counseled about pregnancy precautions, risks of fetal exposure and other risks. The counseling must be done before the initiation of the study and every 28 days before the study drug is dispensed to the subject. FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix D: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Able to take aspirin (81 mg) daily as prophylactic anticoagulation (Patients intolerant to ASA may use warfarin or low molecular weight heparin).
- Able to understand and willing to sign a written informed consent document.
- Life expectancy > or = 12 weeks
Exclusion Criteria
Concomitant Medications:
- Patients may not be receiving any other anti-cancer therapy.
- Patients may not be receiving any other investigational agents.
- Patients may not be receiving systemic steroids or other immunosuppressive drugs; however, steroid containing inhaler may be allowed after discussing with the Principal Investigator. Duration of 5 half-lives must have elapsed before the study registration if the patient was on systemic steroids or other immunosuppressive drugs.
- Patients with untreated brain metastasis, or with treated brain metastasis but requiring steroids.
- Patients with known EGFR mutation or EML-ALK fusion gene and with stage IV disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, autoimmune disease or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breastfeeding women are excluded from this study because lenalidomide has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide.
- Known sera-positive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Any other clinically significant medical condition and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
공부 계획
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: Lenalidomide
Oral lenalidomide 10 mg daily until disease progression
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lenalidomide 10mg/day orally until disease progression
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression free survival
기간: up to 6 months from the date of registration
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Progression free survival is defined as the duration of time from the date starting lenalidomide to the date of documented radiographic progression or death.
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up to 6 months from the date of registration
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2차 결과 측정
결과 측정 |
기간 |
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Number of participants with adverse events
기간: From date of registration to end of study, up to 3 years
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From date of registration to end of study, up to 3 years
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Change in circulating immune cells
기간: Change from baseline at 1 week
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Change from baseline at 1 week
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Change in circulating immune cells
기간: Change from baseline at 5 weeks
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Change from baseline at 5 weeks
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Change in circulating immune cells
기간: Change from baseline at 9 weeks
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Change from baseline at 9 weeks
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Change in circulating immune cells
기간: Change from baseline at 13, 17, 21 and 25 weeks
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Change from baseline at 13, 17, 21 and 25 weeks
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Change in circulating immune cells
기간: Change from baseline to 6 months, 9 months and 1 year
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Change from baseline to 6 months, 9 months and 1 year
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Change in circulating immune cells
기간: Change from baseline to 1.5, 2, 2.5 and 3 years
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Change from baseline to 1.5, 2, 2.5 and 3 years
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jun Zhang, M.D., Baylor College of Medicine
간행물 및 유용한 링크
일반 간행물
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연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
암종, 비소세포폐에 대한 임상 시험
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국
Lenalidomide에 대한 임상 시험
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Johns Hopkins All Children's Hospital종료됨
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Mingzhi Zhang알려지지 않은
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The First Affiliated Hospital of Soochow UniversityThe First Affiliated Hospital with Nanjing Medical University; Jiangsu Province Hospital... 그리고 다른 협력자들모병
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Celgene Corporation완전한새로 진단된 다발성 골수종스페인, 네덜란드, 오스트리아, 호주, 이탈리아, 러시아 연방, 영국, 이스라엘, 벨기에, 그리스, 독일, 폴란드, 칠면조, 프랑스, 덴마크, 체코 공화국, 벨라루스, 그루지야, 아일랜드, 스웨덴, 스위스, 우크라이나
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University of LeedsMerck Sharp & Dohme LLC; Celgene; Amgen알려지지 않은