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Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

2018년 1월 8일 업데이트: Alliance for Clinical Trials in Oncology

Phase I/II Trial of Rituximab, Cladribine, and Temsirolimus (RCT) Therapy in Newly Diagnosed Mantle Cell Lymphoma (MCL)

This phase I/II trial studies the side effects and best dose of temsirolimus when given together with cladribine and rituximab and to see how well it works in treating patients with newly diagnosed mantle cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

PRIMARY OBJECTIVES:

I. To assess the efficacy and safety of the combination of rituximab, cladribine, and temsirolimus for newly diagnosed mantle cell lymphoma.

II. To determine the maximum tolerated dose (MTD) of temsirolimus combined with a fixed dose and schedule of rituximab and cladribine. (Phase I) III. To assess the efficacy of the combination of rituximab, cladribine, and temsirolimus for newly diagnosed mantle cell lymphoma with the proportion of complete responses as the primary endpoint. (Phase II)

SECONDARY OBJECTIVES:

I. To assess other measures of efficacy of the regimen including progression free survival, duration of response, and overall survival.

II. To assess the toxicity profile of the combination of rituximab, cladribine, and temsirolimus.

III. To assess efficacy using traditional lymphoma parameters and absolute lymphocyte count.

IV. To assess metabolic markers (hyperglycemia, hyperlipidemia) as markers of mammalian target of rapamycin (mTOR) inhibition using the glucose and lipid measurements being performed in the clinical laboratory as part of routine care.

V. To correlate response with serum free light chains, single nucleotide polymorphisms (SNPs) in host immune genes, vitamin D metabolites, and phosphatidylinositide 3-kinase (PI3K) pathway member expression.

VI. As part of ongoing research for North Central Cancer Treatment Group (NCCTG) lymphoma studies, paraffin-embedded tissue blocks/slides and blood products will be banked for future studies.

OUTLINE: This is a phase I, dose-escalation study of temsirolimus followed by a phase II study.

Patients receive rituximab intravenously (IV) on day 1 and cladribine IV over 2 hours on days 1-5. Patients then receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive filgrastim subcutaneously (SC) on days 6-15 or pegfilgrastim SC on day 6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 4 months for 3 years.

연구 유형

중재적

등록 (예상)

74

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85259-5499
        • Mayo Clinic Scottsdale
    • Illinois
      • Bloomington, Illinois, 미국, 61701
        • Illinois CancerCare - Bloomington
      • Bloomington, Illinois, 미국, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, 미국, 61520
        • Illinois CancerCare - Canton
      • Canton, Illinois, 미국, 61520
        • Graham Hospital
      • Carthage, Illinois, 미국, 62321
        • Memorial Hospital
      • Carthage, Illinois, 미국, 62321
        • Illinois CancerCare - Carthage
      • Eureka, Illinois, 미국, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, 미국, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, 미국, 61401
        • Illinois CancerCare - Galesburg
      • Galesburg, Illinois, 미국, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, 미국, 62644
        • Mason District Hospital
      • Havana, Illinois, 미국, 62644
        • Illinois CancerCare - Havana
      • Kewanee, Illinois, 미국, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, 미국, 61455
        • Illinois CancerCare - Macomb
      • Macomb, Illinois, 미국, 61455
        • Mcdonough District Hospital
      • Monmouth, Illinois, 미국, 61462
        • Illinois CancerCare - Monmouth
      • Monmouth, Illinois, 미국, 61462
        • OSF Holy Family Medical Center
      • Normal, Illinois, 미국, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, 미국, 61761
        • Community Cancer Center
      • Normal, Illinois, 미국, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, 미국, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, 미국, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, 미국, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Pekin, Illinois, 미국, 61603
        • Illinois CancerCare - Pekin
      • Peoria, Illinois, 미국, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, 미국, 61614
        • Proctor Hospital
      • Peoria, Illinois, 미국, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, 미국, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, 미국, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, 미국, 61354
        • Illinois CancerCare - Peru
      • Peru, Illinois, 미국, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, 미국, 61356
        • Perry Memorial Hospital
      • Princeton, Illinois, 미국, 61356
        • Illinois CancerCare - Princeton
      • Spring Valley, Illinois, 미국, 61362
        • Illinois CancerCare - Spring Valley
    • Indiana
      • Elkhart, Indiana, 미국, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, 미국, 46514-2098
        • Elkhart Clinic, LLC
      • Elkhart, Indiana, 미국, 46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Kokomo, Indiana, 미국, 46904
        • Howard Community Hospital
      • La Porte, Indiana, 미국, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, 미국, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, 미국, 46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth, Indiana, 미국, 46563
        • Michiana Hematology Oncology PC - Plymouth
      • South Bend, Indiana, 미국, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, 미국, 46601
        • CCOP - Northern Indiana CR Consortium
      • Westville, Indiana, 미국, 46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Ames, Iowa, 미국, 50010
        • McFarland Clinic, PC
      • Cedar Rapids, Iowa, 미국, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, 미국, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Clive, Iowa, 미국, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Des Moines, Iowa, 미국, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, 미국, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, 미국, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, 미국, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, 미국, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, 미국, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Mason City, Iowa, 미국, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Sioux City, Iowa, 미국, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, 미국, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, 미국, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, 미국, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, 미국, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, 미국, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, 미국, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, 미국, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, 미국, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, 미국, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, 미국, 67901
        • Cancer Center of Kansas, PA - Liberal
      • Newton, Kansas, 미국, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, 미국, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, 미국, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, 미국, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, 미국, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, 미국, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, 미국, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, 미국, 67214
        • CCOP - Wichita
      • Wichita, Kansas, 미국, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, 미국, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, 미국, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Battle Creek, Michigan, 미국, 49017
        • Battle Creek Health System Cancer Care Center
      • Big Rapids, Michigan, 미국, 49307
        • Mecosta County Medical Center
      • Escanaba, Michigan, 미국, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Grand Rapids, Michigan, 미국, 49503
        • Butterworth Hospital at Spectrum Health
      • Grand Rapids, Michigan, 미국, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, 미국, 49503
        • Lacks Cancer Center at Saint Mary's Health Care
      • Iron Mountain, Michigan, 미국, 49801
        • Dickinson County Healthcare System
      • Muskegon, Michigan, 미국, 49443
        • Mercy General Health Partners
      • Niles, Michigan, 미국, 49120
        • Michiana Hematology Oncology PC - Niles
      • Saint Joseph, Michigan, 미국, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, 미국, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Traverse City, Michigan, 미국, 49684
        • Munson Medical Center
      • Wyoming, Michigan, 미국, 49519
        • Metro Health Hospital
    • Minnesota
      • Burnsville, Minnesota, 미국, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, 미국, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, 미국, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, 미국, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, 미국, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, 미국, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, 미국, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, 미국, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, 미국, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, 미국, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, 미국, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, 미국, 55415
        • Hennepin County Medical Center - Minneapolis
      • Robbinsdale, Minnesota, 미국, 55422-2900
        • Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, 미국, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, 미국, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, 미국, 55102
        • United Hospital
      • Saint Paul, Minnesota, 미국, 55101
        • Regions Hospital Cancer Care Center
      • Shakopee, Minnesota, 미국, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Stillwater, Minnesota, 미국, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, 미국, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, 미국, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, 미국, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
    • Montana
      • Billings, Montana, 미국, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, 미국, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, 미국, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, 미국, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, 미국, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, 미국, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, 미국, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, 미국, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Havre, Montana, 미국, 59501
        • Northern Montana Hospital
      • Helena, Montana, 미국, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, 미국, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, 미국, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, 미국, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, 미국, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • North Dakota
      • Bismarck, North Dakota, 미국, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, 미국, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, 미국, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, 미국, 58502
        • St. Alexius Medical Center Cancer Center
    • South Dakota
      • Rapid City, South Dakota, 미국, 57701
        • Rapid City Regional Hospital
    • Wisconsin
      • Green Bay, Wisconsin, 미국, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, 미국, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, 미국, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, 미국, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Manitowoc, Wisconsin, 미국, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, 미국, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, 미국, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sheboygan, Wisconsin, 미국, 53081
        • St. Nicholas Hospital
      • Sturgeon Bay, Wisconsin, 미국, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Sheridan, Wyoming, 미국, 82801
        • Welch Cancer Center at Sheridan Memorial Hospital

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Histologically confirmed mantle cell lymphoma (MCL); the diagnosis must be confirmed by NCCTG pre-registration pathology review by Dr. Paul Kurtin or his designate; it is recommended that the biopsy be an excisional biopsy, but adequate core-needle biopsies will be accepted as long as they are considered adequate for registration by Dr. Kurtin or his designate; the tumor must be cyclin D-1 positive by immunohistochemistry or have evidence of a t(11;14) translocation by fluorescence based in situ hybridization (FISH) or cytogenetics

  • Measurable or assessable disease, defined as at least one of the following:

    • A lymph node or tumor mass that is >= 2.0 cm in at least one dimension by positron emission tomography (PET)/computed tomography (CT), CT, magnetic resonance imaging (MRI), or plain radiograph imaging
    • Splenic enlargement may be used as a measurable parameter if the spleen is palpable >= 3 cm below the left costal margin
    • Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without a discrete mass would constitute assessable, but not measurable, disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3
  • Life expectancy >= 12 weeks
  • Absolute neutrophil count (ANC) >= 1,500/mm³
  • Platelet count (PLT) >= 100,000/mm³
  • Serum creatinine =< 2.0 mg/dL
  • Serum total bilirubin (or direct bilirubin if total is abnormal) =< institutional upper limit of normal (ULN) with or without secondary liver involvement
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x institutional ULN (exception: if there is liver involvement, SGOT must be =< 5 x institutional ULN)
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Willingness to return to NCCTG enrolling institution for follow-up
  • Willingness to provide the blood specimens as required by the protocol
  • Willingness to provide tissue specimens as required by the protocol
  • Willing to return to NCCTG enrolling institution for follow-up
  • Willing to provide blood and tissue specimens as required by the protocol
  • Willing to abstain from eating grapefruit or drinking grapefruit juice
  • Willingness to abstain from eating grapefruit or drinking grapefruit juice for the duration of the study

Exclusion Criteria

  • Any prior therapy for mantle cell non-Hodgkin lymphoma including radiation therapy; exception: patient may have undergone a splenectomy for diagnosis, cytopenia, or systematic splenomegaly
  • Active or uncontrolled infection

  • Any of the following cardiac conditions:

    • Uncontrolled high blood pressure
    • Unstable angina
    • Active congestive heart failure
    • Myocardial infarction =< 6 months
    • Serious uncontrolled cardiac arrhythmia
  • Known central nervous system (CNS) involvement

  • Any of the following:

    • Pregnant women or women of reproductive ability who are unwilling to use effective contraception while taking the drug and for 12 months after stopping treatment
    • Nursing women
    • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 12 months after stopping treatment
  • Medical or psychiatric conditions which, in the opinion of the investigator, make the patient a poor risk for participation
  • Known to be human immunodeficiency virus (HIV) positive; HIV testing is not required but should be done if clinically indicated; HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
  • Concurrent malignancy =< 5 years ago; exceptions: carcinoma in situ of the cervix, resected basal cell or squamous cell carcinomas of the skin, or prostate cancer that is in remission following a radical retropubic prostatectomy or radiation therapy; if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • Known hypersensitivity to rituximab or its components, or to murine proteins
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Prior treatment with an mTOR inhibitor
  • Autologous or allogeneic stem cell transplant planned as part of initial therapy
  • Receiving enzyme-inducing antiepileptic drugs (enzyme inducing anti-epileptic drugs [EIAEDs]; e.g., phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, phenobarbital, or primidone); any other potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin, glucocorticoids at greater than adrenal replacement levels, or St. John's wort; or receiving strong CYP3A4 inhibitors * Note: if these agents are discontinued, temsirolimus therapy can begin >= 7 days after discontinuation of such agent

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
실험적: Treatment (rituximab, cladribine, temsirolimus)
Patients receive rituximab IV on day 1 and cladribine IV over 2 hours on days 1-5. Patients then receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive filgrastim SC on days 6-15 or pegfilgrastim SC on day 6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
생물학적: 페그필그라스팀
생물학적: rituximab
Give IV
의약품: cladribine
Give IV
의약품: temsirolimus
Give IV
생물학적: Filgrastim
Give SC

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Number of dose limiting toxicity incidents as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 3.0 (Phase I)
기간: 28 days
28 days
Proportion of complete tumor responses defined as complete remission (CR) as the objective status (Phase II)
기간: Up to 5 years
Up to 5 years

2차 결과 측정

결과 측정
기간
전반적인 생존
기간: 최대 5년
최대 5년
생존 시간
기간: 최대 5년
최대 5년
Progression-free survival (PFS)
기간: up to 5 years
up to 5 years
Time to disease progression
기간: up to 5 years
up to 5 years
Duration of response, defined as date at which the patient's objective status is first noted to be either a CR or partial remission to the date progression is documented
기간: Up to 5 years
Up to 5 years
Frequency and severity of adverse events assessed by CTCAE v3.0
기간: Up to 5 years
Up to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: David J. Inwards, MD, Mayo Clinic

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 (실제)

2009년 4월 1일

기본 완료 (실제)

2012년 4월 1일

연구 완료 (실제)

2017년 6월 15일

연구 등록 날짜

최초 제출

2008년 11월 7일

QC 기준을 충족하는 최초 제출

2008년 11월 7일

처음 게시됨 (추정)

2008년 11월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 1월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 1월 8일

마지막으로 확인됨

2018년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCCTG-N078D
  • NCI-2009-00669 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
  • CDR0000619329 (레지스트리 식별자: PDQ (Physician Data Query))

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. .

페그필그라스팀에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Bulgaria

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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