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

2. Oktober 2018 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

104

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: 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
Experimental: 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
Arzneimittel: 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
Experimental: 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
Arzneimittel: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-emergent Adverse Events
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Response Rate (ORR)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Celgene

Ermittler

  • Studienleiter: Jeffery Jones, M.D., MPH, Celgene Corporation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Oktober 2009

Primärer Abschluss (Tatsächlich)

5. September 2017

Studienabschluss (Tatsächlich)

5. September 2017

Studienanmeldedaten

Zuerst eingereicht

20. August 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2009

Zuerst gepostet (Schätzen)

21. August 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Oktober 2018

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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