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A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma

18 de março de 2018 atualizado por: Celgene

A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma

To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

26

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Japão
      • Fukuoka, Japão, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japão, 812-8582
        • Kyushu University Hospital
      • Kagoshima, Japão, 892-0853
        • National Hospital Organization Kagoshima Medical Center
      • Kagoshima, Japão, 890-8520
        • Kagoshima University Medical and Dental Hospital
      • Kagoshima, Japão, 890-0064
        • Imamura Bunin Hospital
      • Kumamoto, Japão, 860-8556
        • Kumamoto University Hospital
      • Nagasaki, Japão, 852-8501
        • Nagasaki University Hospital
      • Nagasaki, Japão, 852-8511
        • The Japanese Red Cross Nagasaki Genbaku Hospital
      • Oita, Japão, 870-8511
        • Oita Prefectual Hospital
      • Tokyo, Japão, 104-0045
        • National Cancer Center Hospital
    • Aichi
      • Nagoya, Aichi, Japão, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Kashiwa, Chiba, Japão, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Toon, Ehime, Japão, 791-0295
        • Ehime University Hospital
    • Iwate
      • Morioka, Iwate, Japão, 020-8505
        • Iwate Medical University Hospital
    • Miyagi
      • Sendai, Miyagi, Japão, 980-8574
        • Tohoku University Hospital
    • Nagasaki
      • Sasebo, Nagasaki, Japão, 857-8511
        • Sasebo City General Hospital
    • Okinawa
      • Nakagami, Okinawa, Japão, 901-2492
        • Heart Life Hospital
    • Shimane
      • Izumo, Shimane, Japão, 693-8501
        • Shimane University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Must understand and voluntarily sign the informed consent
  • Aged 20 years or older (at the time of signing the informed consent)
  • Have a documented diagnosis of either: acute-, lymphoma-, or unfavorable chronic-type adult T-cell leukemia-lymphoma
  • Have received ≥1 prior anti-adult T-cell leukemia-lymphoma therapy, have achieved stable disease or better on their immediately prior therapy and have relapsed or progressed at the time of obtaining signed informed consent
  • Subjects for whom at least 1 measurable lesion (measurable lesion of computed tomography scan, peripheral blood or skin lesion) is confirmed in the lesion assessment before registration
  • Have an Eastern Cooperative Oncology Group performance status of 0 to 2 at registration
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Exclusion Criteria:

  • Have a history of central nervous system involvement or present with central nervous system symptoms, and are diagnosed with central nervous system lymphoma by cerebrospinal fluid cytology examination, head computed tomography scan or brain magnetic resonance imaging during the screening
  • Are pregnant or lactating

  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. Examples of such medical condition are, but are not limited to, as follows:

    • Uncontrolled diabetes mellitus as defined by the investigator or sub-investigator
    • Chronic congestive heart failure (New York Heart Association Class III or IV)
    • Unstable angina pectoris, angioplasty, stenting, or myocardial infarction (within 6 months before starting the study drug)
    • Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia (subjects with controlled atrial fibrillation that is asymptomatic are eligible for this study)
    • Major surgery within 28 days of the start of study treatment
  • Exhibit grade 4 neurological disorders
  • Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic prophylaxis.
  • Develop active tuberculous disease, herpes simplex, systemic mycosis, or other active infections requiring systemic administration of antibiotics, antiviral agents, or antifungal drugs
  • Known human immunodeficiency virus positivity
  • Have hepatitis B surface antigen-positive, or hepatitis C virus anti-body positive. In case hepatitis B core antibody and/or hepatitis B surface antibody is positive even if hepatitis B surface antigen-negative, a hepatitis B virus deoxyribonucleic acid test should be performed and if positive the subject will be excluded
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Have a history of allogenic stem cell transplantation
  • Have received autologous stem cell transplantation within 12 weeks (84 days) of the start of study treatment
  • Have previously used lenalidomide
  • Have a history of desquamating (blistering) rash while taking thalidomide
  • Have received any investigational drugs (unapproved drugs in Japan) within 4 weeks (28 days) of the start of study medication
  • Have received any antibody agents within 12 weeks (84 days) of the start of study medication
  • Have received chemotherapeutic agents or immunomodulatory drugs for the treatment of adult T-cell leukemia-lymphoma within 4 weeks (28 days) of the start of study treatment
  • Have received radiotherapy within 4 weeks (28 days) of the start of study treatment

  • Have a history or complication of another malignant tumor other than adult T-cell leukemia-lymphoma and the following malignant tumors, unless the patients have been free of the disease for 5 years or longer

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Cervical carcinoma in situ
    • Carcinoma in situ of the breast
    • An incidental histological finding of prostate carcinoma (TNM stage T1a or T1b)
    • Early-stage gastric cancer treated with endoscopic mucosal resection or endoscopic submucosal dissection

  • Have had any of the following abnormal measurements at screening performed within 1 week (7 days) prior to the registration;

    • Neutrophil count: < 1,200/µL
    • Platelet count: < 75,000/µL
    • Serum aspartate aminotransferase/glutamyl oxaloacetic transaminase or alanine aminotransferase/glutamyl pyruvic transaminase: > 3 times the upper limit of normal
    • Bilirubin level: > 1.5 times the upper limit of normal
    • Creatinine clearance: < 60 mL/min
  • Any condition that confounds the ability to interpret data from the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Lenalidomide
Lenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity
Medicamento: Lenalidomide
25 mg of Lenalidomide administered orally once daily
Outros nomes:
  • Revlimid

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)
Prazo: From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is "negative" and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared
From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC
Prazo: From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks
PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.
From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks
Kaplan-Meier Estimate of Time to Progression (TTP)
Prazo: From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks
Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC
From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks
Number of Participants With Treatment Emergent Adverse Events
Prazo: From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks
Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks
Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC
Prazo: From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks
The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.
From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks
Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC
Prazo: From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.
From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
Kaplan-Meier Estimate for Overall Survival
Prazo: From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks
Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.
From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Time to Response
Prazo: From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks
Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)
From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Celgene

Investigadores

  • Diretor de estudo: Toru Sasaki, Celgene K.K.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

12 de novembro de 2012

Conclusão Primária (Real)

20 de novembro de 2014

Conclusão do estudo (Real)

21 de março de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

7 de novembro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de novembro de 2012

Primeira postagem (Estimativa)

9 de novembro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de maio de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de março de 2018

Última verificação

1 de março de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CC-5013-ATLL-002

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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