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Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

2018년 10월 2일 업데이트: Celgene

A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

104

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일, 13353
        • Charité -Universitätsmedizin Berlin
      • Essen, 독일, 45122
        • Universitätsklinikum Essen
      • Greifswald, 독일, 17487
        • Ernst-Moritz-Arndt-Universität Greifswald
      • Kiel, 독일, 24116
        • Universitatsklinikum Schleswig Holstein
      • Köln, 독일, 50924
        • Klinikum der Universität zu Köln
      • Ulm, 독일, 89081
        • University of Ulm Abteilung Innere Medizin III
  • 미국
    • California
      • La Jolla, California, 미국, 92093-0820
        • UCSD Moores Cancer Center
      • Rancho Mirage, California, 미국, 92270
        • Desert Hematology Oncology Medical Group, Inc.
      • Stanford, California, 미국, 94305-5821
        • Stanford University School of Medicine
    • Connecticut
      • Southington, Connecticut, 미국, 06489
        • Cancer Center of Central Connecticut
    • Florida
      • Lecanto, Florida, 미국, 34461
        • Cancer and Blood Disease Center
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • Rush University Medical Center
      • Chicago, Illinois, 미국, 60611-2927
        • Northwestern University Medical Center Division of Hematology Oncology
    • Indiana
      • Indianapolis, Indiana, 미국, 46202-5149
        • Indiana University Cancer Center
    • Michigan
      • Detroit, Michigan, 미국, 48201
        • Karmanos Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • Hackensack University Medical Center
    • New York
      • Buffalo, New York, 미국, 14263
        • Roswell Park Cancer Institute
      • New Hyde Park, New York, 미국, 11042
        • Long Island Jewish Medical Center CLL Research and Treatment Program
    • North Carolina
      • Winston-Salem, North Carolina, 미국, 27104
        • Wake Forest University School of Medicine
    • Ohio
      • Canton, Ohio, 미국, 44718
        • Gabrail Cancer Center Research
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19102
        • Drexel University, College of Medicine, Clinical Research Group
  • 스웨덴
      • Stockholm, 스웨덴, 14186
        • Karolinska Universitetssjukhuset
  • 스페인
      • Barcelona, 스페인, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, 스페인, 08036
        • Hospital Clinic Provincial De Barcelona
  • 영국
      • Leeds, 영국, LS9 7TF
        • St James's Institute of Oncology
      • London, 영국, SE5 9RS
        • King's College Hospital
      • London, 영국, SW3 6JJ
        • The Royal Marsden Hospital
      • London, 영국, EC1M 6BQ
        • St.Bartholomew's Hospital
      • Manchester, 영국, M20 4BX
        • Christie Hospital NHS Foundation Trust
  • 이탈리아
      • Genova, 이탈리아, 16132
        • Azienda Ospedaliera Universitaria San Martino
      • Lecce, 이탈리아, 73100
        • Ematologia ed Immunologia, Azienda Ospedaliera "Vito Fazzi" di Lecce
      • Milano, 이탈리아, 20141
        • Istituto Europeo Di Oncologia - IEO
      • Milano, 이탈리아, 20132
        • I.R.C.C.S. Ospedale San Raffaele
      • Padova, 이탈리아, 35128
        • Universita Degli Studi Di Padova
      • Perugia, 이탈리아, 06100
        • Universita' degli Studi di Perugia
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, 캐나다, L8V 5C2
        • Juravinski Cancer Centre
  • 프랑스
      • Amiens, 프랑스, 80054
        • CHU Sud
      • Bobigny Cedex, 프랑스, 93009
        • Hopital Avicenne
      • Grenoble Cedex 09, 프랑스, 38043
        • Chu Grenoble
      • Le Mans, 프랑스, 72000
        • Clinique Victor Hugo
      • Marseille Cedex 9, 프랑스, 13273
        • Institut Paoli Calmettes
      • Montpellier Cedex 5, 프랑스, 34295
        • CHU Montpellier - Hôpital Saint Eloi
      • Mulhouse, 프랑스, 68000
        • Hopital Emile Muller
      • Paris, 프랑스, 75651
        • Hôpital Pitie Salpétrière
      • Perpignan, 프랑스, 66046
        • CH Perpignan - Hopital Saint-Jean
      • Pessac, 프랑스, 33604
        • CHRU - Hôpital du Haut Lévêque
      • Pierre Bénite, 프랑스, 69310
        • Centre Hospitalier LYON SUD
      • REIMS cedex, 프랑스, 51092
        • Hopital Robert Debre
      • Rennes cedex, 프랑스, 35033
        • CHU Rennes Hematology
      • Vandoeuvre les Nancy, 프랑스, 54511
        • CHRU Hopital Brabois

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:

  • Age ≥ 18 years at the time of signing the informed consent form
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must have a documented diagnosis of B-cell CLL
  • Must be relapsed or refractory to at least 1 regimen for treatment of CLL. At least one of the prior treatments must have included a purine analog-based or bendamustine-based regimen
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Active infections requiring systemic antibiotics
  • Systemic treatment for B-cell CLL within 28 days of initiation of lenalidomide treatment
  • Alemtuzumab therapy within 120 days of initiating lenalidomide treatment
  • Prior therapy with lenalidomide
  • History of grade 4 rash due to prior thalidomide treatment
  • Planned autologous or allogeneic bone marrow transplantation
  • Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Venous thromboembolism within 12 months
  • ≥ Grade 2 neuropathy
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
  • Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating lenalidomide therapy

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Lenalidomide 5 mg

Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.

Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
의약품: lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

  • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
실험적: Lenalidomide 10 mg

Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.

Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
의약품: lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

  • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity
실험적: Lenalidomide 15 mg

Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.

Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug
의약품: lenalidomide

Depending on the starting dose, subjects will be allocated in a double-blind fashion to three different regimens and will escalate every 28 days, based on individual subject tolerability, as follows:

  • Treatment Arm 1: 5 mg →10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 2: 10 mg →15 mg →20 mg →25 mg/daily
  • Treatment Arm 3: 15 mg →20 mg →25 mg/daily Subjects will continue treatment until disease progression or unacceptable toxicity

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-emergent Adverse Events
기간: From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.
Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.
From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Response Rate (ORR)
기간: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL.
Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Kaplan-Meier Estimate of Duration of Response
기간: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.
Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Time to Response
기간: Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.
Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Kaplan-Meier Estimate of Time to Progression
기간: From randomization until the end of the study; maximum time on study was 91 months.
Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.
From randomization until the end of the study; maximum time on study was 91 months.
Kaplan-Meier Estimate of Event-Free Survival
기간: From randomization until the end of the study; maximum time on study was 91 months.
Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
From randomization until the end of the study; maximum time on study was 91 months.
Kaplan-Meier Estimate of Progression Free Survival
기간: From randomization until the end of the study; maximum time on study was 91 months.
Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
From randomization until the end of the study; maximum time on study was 91 months.
Kaplan-Meier Estimate of Overall Survival
기간: From randomization until the end of the study; maximum time on study was 91 months.
Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.
From randomization until the end of the study; maximum time on study was 91 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Celgene

수사관

  • 연구 책임자: Jeffery Jones, M.D., MPH, Celgene Corporation

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 10월 19일

기본 완료 (실제)

2017년 9월 5일

연구 완료 (실제)

2017년 9월 5일

연구 등록 날짜

최초 제출

2009년 8월 20일

QC 기준을 충족하는 최초 제출

2009년 8월 20일

처음 게시됨 (추정)

2009년 8월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 2일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CC-5013-CLL-009
  • 2009-009836-54 (EudraCT 번호)

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. .

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