Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Reduced Intensity Double Umbilical Cord Blood Transplantation

29 de dezembro de 2018 atualizado por: Zachariah Michael DeFilipp, Massachusetts General Hospital

A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation

This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.

Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Subjects will receive their transplants as in-patients.

  • IV-Catheter

    • one or two IV catheters will be placed on the day of hospital admission

  • Conditioning

    • Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
    • Melphalan IV (day -1)
    • Total body radiation on day 0 (same day as transplant)

  • Immunosuppressive Therapy

    • Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient

  • Infusion of Cord Blood units

    • 2 cord blood units IV on Day 0 Routine post-transplant supportive care will be provided

Tipo de estudo

Intervencional

Inscrição (Real)

33

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

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Estados Unidos, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General 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

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
  • Appropriate candidate for reduced intensity regimen, according to the treating physician
  • Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
  • Able to comply with the requirements for care after allogeneic stem cell transplantation

Exclusion Criteria:

  • Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
  • Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
  • Renal disease
  • Hepatic disease
  • Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
  • HIV-positive
  • Uncontrolled infection
  • Pregnant or breast-feeding

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: Fludarabine/Melphalan/TBI
All patients receive same therapy
Medicamento: Fludarabine
30 mg/m2/day IV x 6 days
Outros nomes:
  • Fludara
Medicamento: Melfalano
100 mg/m2/dia IV x 1 dia
Radiação: Total Body Radiation
200 cGy on Day 0
Biológico: Cord Blood
2 cord blood units IV

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With a Clinically Significant Infection
Prazo: 1 Year
The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.
1 Year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Median Time to Neutrophil Engraftment
Prazo: From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days
The median number of days measured from the time of transplantation, until the first documented neutrophil engraftment. neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count > 500 neutrophils per microliter of blood.
From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days
Median Time to Platelet Engraftment
Prazo: From the time of transplantation, until the time of platelet engraftment, median duration of 52 days
The time to platelet engraftment is measured from the time of transplantation until the time of first documented platelet engraftment. Platelet engraftment is defined as a platelet count ≥ 20,000/µL for three consecutive measurements over three or more days. The first of the three days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 3 days or in the following 7 days after the day of engraftment, unless the platelet transfusion is being given specifically to achieve a platelet threshold to allow an elective invasive procedure, such as a central catheter removal.
From the time of transplantation, until the time of platelet engraftment, median duration of 52 days
Number of Participants With Primary Graft Failure
Prazo: From the time of transplantation until 42 days post transplantation
Primary graft failure is defined as the failure to achieve an absolute neutrophil count (ANC) >500/ µL by day 42, in the absence of relapse.
From the time of transplantation until 42 days post transplantation
Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days
Prazo: 100 Days

Acute GVHD is assessed using Consensus Criteria:

Organ Classifications:

  • 0: No rash due to GVHD; Bilirubin < 2 mg/dL; < 500 mL diarrhea/ day
  • 1: Maculopapular rash < 25% of body surface; Bilirubin 2-3 mg/dL; 500 to 999 mL diarrhea/ day or persistent nausea with histologic evidence of GVHD in stomach/ duodenum
  • 2: Maculopapular rash 25-50% of body surface; Bilirubin 3.1-6 mg/dL; 1,000 to 1,499 mL diarrhea/ day
  • 3: Maculopapular rash > 50% of body surface; Bilirubin 6.1-15 mg/dL; 1,500 or more mL diarrhea/ day
  • 4: Generalized erythroderma with bullous formation; Bilirubin > 15 mg/dL; Severe abdominal pain with or without ileus

Overall Clinical Grade:

  • 0: No Stage 1-4 of any organ
  • I: Stage 1-2 rash and no liver or gut involvement
  • II: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gut involvement
  • III: None to Stage 3 skin rash with Stage 2-3 liver involvement, or Stage 2-4 gut involvement
  • IV: Stage 4 skin rash, or Stage 4 liver involvement
100 Days
The Rate of Chronic GVHD
Prazo: From the time of transplantation until the time of chronic GVHD onset, up to 1 year
Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria.
From the time of transplantation until the time of chronic GVHD onset, up to 1 year
100-day Treatment Related Mortality
Prazo: 100 Days
The percentage of treatment related participant deaths within 100 days of receiving umbilical cord blood transplantation. All deaths in the absence of relapse of the primary malignancy will be considered treatment related mortality.
100 Days
Immune Reconstitution - Median CD4 Count at 12 Months
Prazo: 1 Year
1 Year
Relapse-free Survival
Prazo: 2 years
The percentage of participants that have not died or had disease progression by two years. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.
2 years
Overall Survival
Prazo: 2 years
The percentage of participants alive at two years
2 years
1 Year Relapse Rate
Prazo: 1 year
The percentage of participants that relapsed within 12 months. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.
1 year
Rate of Post-transplant Lymphoma
Prazo: 2.5 years
The number of participants that were found to have lymphoma post-transplant.
2.5 years
Median Thrombopoietin Levels After Transplant
Prazo: 30 Days
30 Days

Colaboradores e Investigadores

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

Patrocinador

Massachusetts General Hospital

Investigadores

  • Investigador principal: Zachariah DeFilipp, MD, Massachusetts General Hospital

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

1 de dezembro de 2011

Conclusão Primária (Real)

1 de junho de 2017

Conclusão do estudo (Real)

1 de junho de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

2 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de agosto de 2011

Primeira postagem (Estimativa)

3 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de janeiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de dezembro de 2018

Última verificação

1 de dezembro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 11-085

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 .

Se inscrever