このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2018年10月2日 更新者：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).

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

104

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

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

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

18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:

  • 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

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：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
薬：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
実験的：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
薬：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
実験的：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
薬：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

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
Number of Participants With Treatment-emergent Adverse Events
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Response Rate (ORR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Celgene

捜査官

  • スタディディレクター：Jeffery Jones, M.D., MPH、Celgene Corporation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (実際)

2009年10月19日

一次修了 (実際)

2017年9月5日

研究の完了 (実際)

2017年9月5日

試験登録日

最初に提出

2009年8月20日

QC基準を満たした最初の提出物

2009年8月20日

最初の投稿 (見積もり)

2009年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月31日

QC基準を満たした最後の更新が送信されました

2018年10月2日

最終確認日

2018年10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

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

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。

lenalidomideの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Angola

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する