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A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

17 giugno 2019 aggiornato da: Celgene

A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

88

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • (402) Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z1
        • (405) University of Alberta Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • (401) Cancer Care Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • (403) Queen Elizabeth II Health Sciences Centre - VG Site
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • (404) The Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • (400) Princess Margaret Hospital
  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85724
        • (210) University of Arizona Cancer Center
    • California
      • La Jolla, California, Stati Uniti, 92093-0960
        • (180) University of California, San Diego
      • Los Angeles, California, Stati Uniti, 90048
        • (240) Cedars-Sinai Medical Center
      • Orange, California, Stati Uniti, 92868
        • (215) Hematology Oncology Medical Group
      • Sacramento, California, Stati Uniti, 95857
        • (130) UC Davis Medical Center
      • San Luis Obispo, California, Stati Uniti, 93401
        • (200) Coastal Integrative Cancer Care
      • Stanford, California, Stati Uniti, 94305
        • (125) University of Stanford
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • (115) University of Colorado Anschultz Cancer Center
    • Florida
      • Miami Beach, Florida, Stati Uniti, 33140
        • (145) Mount Sinai Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • (140) Rush University Medical Center
    • Kansas
      • Westwood, Kansas, Stati Uniti, 66205
        • (185) The University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • (175) University Lousiville
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70072
        • (195) Tulane University Hospital Tulane Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • (235) University of Minnesota
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110-1093
        • (100) Washington University School of Medicine
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • (150) Billings Clinic
    • New York
      • New York, New York, Stati Uniti, 10029-65749
        • (165) Mount Sinai Medical Center New York
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15224-1791
        • (160) The Western Pennsylvania Hospital- Cancer Institute
    • South Carolina
      • Greenville, South Carolina, Stati Uniti, 29605
        • (205) Greenville Hospital System
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • (120) Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • (230) Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, Stati Uniti, 75390-9179
        • (105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
      • San Antonio, Texas, Stati Uniti, 78229
        • (155) Cancer Care Centers of South Texas
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792
        • (135) University of Wisconsin

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
  • Male or female subjects aged ≥ 65
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

Exclusion Criteria:

  • Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
  • Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
  • Suspected or proven acute promyelocytic leukemia
  • Prior bone marrow or stem cell transplantation
  • Candidate for allogeneic bone marrow or stem cell transplantation
  • AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
  • Presence of malignant disease within the previous 12 months with exceptions

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
Droga: Azacitidine
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
Altri nomi:
  • Vidazza
Droga: Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Altri nomi:
  • CC-5013
  • Revlim®
Altro: Best Supportive Care (BSC)

The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Sperimentale: Lenalidomide - single agent
Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
Droga: Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Altri nomi:
  • CC-5013
  • Revlim®
Altro: Best Supportive Care (BSC)

The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Sperimentale: Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
Droga: Azacitidine
Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
Altri nomi:
  • Vidazza
Altro: Best Supportive Care (BSC)

The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.

BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Kaplan Meier Estimates for One Year Survival
Lasso di tempo: Up to 24 months
One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation
Up to 24 months
Overall Survival
Lasso di tempo: From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)
Overall Survival reported at the end of the study are for those participants who were alive at the end of the study
From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
Lasso di tempo: Complete Response or Morphologic Incomplete Response data not analyzed.

Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.

Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Complete Response or Morphologic Incomplete Response data not analyzed.
Duration of Remission (DoR)
Lasso di tempo: Duration of Remission (DoR) time frame not analyzed.
Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Duration of Remission (DoR) time frame not analyzed.
Cytogenetic Complete Remission Rate (CRc)
Lasso di tempo: Cytogenetic Complete Remission timeframe was not analyzed.
The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Cytogenetic Complete Remission timeframe was not analyzed.
Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)
Lasso di tempo: Overall response rate time frame was not analyzed.
Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission was defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Overall response rate time frame was not analyzed.
Progression-Free Survival (PFS)
Lasso di tempo: Progression-Free survival data and time frame was not analyzed.
PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Progression-Free survival data and time frame was not analyzed.
Event-Free Survival (EFS)
Lasso di tempo: Event-Free survival time was not analyzed.
EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Event-Free survival time was not analyzed.
Relapse-Free Survival (RFS)
Lasso di tempo: Relapse-Free survival time frame was not analyzed.
RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.
Relapse-Free survival time frame was not analyzed.
Percentage of Participants With 30-Day Treatment-Related Mortality
Lasso di tempo: 30 days
30-day mortality rate was defined as death from any cause within 30 days after first dose.
30 days
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Lasso di tempo: From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
Number of Participants With a Second Primary Malignancy
Lasso di tempo: From randomization of the last participant up to a minimum of 4 years following discontinuation
Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.
From randomization of the last participant up to a minimum of 4 years following discontinuation

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Alive at One Year
Lasso di tempo: Up to 12 months
Defined as the percentage of participants who survived at one year
Up to 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Celgene

Investigatori

  • Direttore dello studio: Robert Gale, MD, Celgene

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 aprile 2012

Completamento primario (Effettivo)

19 maggio 2015

Completamento dello studio (Effettivo)

15 maggio 2018

Date di iscrizione allo studio

Primo inviato

19 maggio 2011

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2011

Primo Inserito (Stima)

24 maggio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2019

Ultimo verificato

1 giugno 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CC-5013-AML-001

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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