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Donor Mesenchymal Stem Cell Infusion in Treating Patients With Acute or Chronic Graft-Versus-Host Disease After Undergoing a Donor Stem Cell Transplant

4. november 2010 opdateret af: Case Comprehensive Cancer Center

Donor Mesenchymal Stem Cell Infusion for Treatment of Graft Versus Host Disease: A Phase I Trial

RATIONALE: Donor mesenchymal stem cell infusion may be an effective treatment for acute or chronic graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This phase I trial is studying the side effects and best dose of donor mesenchymal stem cells in treating patients with acute or chronic graft-versus-host disease after undergoing a donor stem cell transplant.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the safety of donor mesenchymal stem cell (MSC) infusion in patients with acute or extensive chronic graft-vs-host disease (GVHD) after undergoing HLA-identical sibling donor stem cell transplant.

Secondary

  • Describe the rates of complete and partial resolution of GVHD when MSCs are used in addition to the standard GVHD therapy.
  • Determine inflammatory cytokine levels, lymphocyte subsets, and donor-reactive lymphocyte numbers in blood of patients with acute GVHD prior to therapy and at 7 and 14 days post-MSC therapy.
  • Determine if donor MSCs engraft in tissues inflamed by GVHD in patients who have undergone gender-mismatched transplantation.

OUTLINE: This is a multicenter, dose-escalation study of donor mesenchymal stem cells (MSC).

Within 72 hours after the initiation of medical therapy (e.g., corticosteroids, cyclosporine) for graft-vs-host disease, patients undergo donor MSC infusion over 10-15 minutes.

Cohorts of 3-6 patients receive escalating doses of donor MSCs until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Blood samples are obtained periodically and examined by immunoenzyme techniques for mixed lymphocyte reaction (as a surrogate marker for alloreactivity) and cytokine levels (TH1 [i.e., interleukin (IL)-2 and interferon-gamma], TH2 [i.e., IL-10 and IL-4], and inflammatory cytokines [i.e., tumor necrosis factor-alpha and IL-1]). Tissue specimens are examined by CD45 immunohistochemistry and fluorescent in situ hybridization to detect hematopoietic and nonhematopoietic cells.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

49

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44024
        • Geauga Regional Hospital
      • Cleveland, Ohio, Forenede Stater, 44060
        • Lake/University Ireland Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44121
        • University Suburban Health Center
      • Cleveland, Ohio, Forenede Stater, 44122
        • UHHS Chagrin Highlands Medical Center
      • Cleveland, Ohio, Forenede Stater, 44130
        • Southwest General Health Center
      • Cleveland, Ohio, Forenede Stater, 44145
        • UHHS Westlake Medical Center
      • Cleveland, Ohio, Forenede Stater, 44708
        • Mercy Cancer Center at Mercy Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Developed acute graft-vs-host disease (GVHD) of clinical grade II-IV or extensive chronic GVHD after undergoing HLA-identical sibling donor hematopoietic stem cell transplant for any indication, malignant or nonmalignant

    • Requires systemic immunosuppressive therapy with systemic corticosteroids (methylprednisone dose 2 mg/kg/day or equivalent) and concurrent cyclosporine or tacrolimus
  • May have been enrolled on an institutional allogeneic stem cell transplant protocol using either ablative or nonmyeloablative preparative regimens
  • No evidence of relapsed or progressive malignant disease at the time of GVHD

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Negative pregnancy test
  • Creatinine clearance ≥ 20 mL/min
  • Oxygen saturation ≥ 90% on room air
  • No severe or symptomatic restrictive or obstructive lung disease or respiratory failure requiring ventilator support
  • No uncontrolled hypertension or congestive heart failure, active angina pectoris requiring the use of nitrates, myocardial infarction within the past 6 months, or major ventricular arrhythmia or cardiac failure requiring active treatment
  • No significant organ dysfunction

  • No active severe infections, including sepsis, pneumonia with hypoxemia, persistent bacteremia, or meningitis

    • Fever without a source is allowed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Safety
Tidsramme: Monitored for 6 hours for infusion related toxicity. Temperature, blood pressure, pulse and O2 saturation will be measured at baseline and every 10 minutes x 2, every 30 minutes x 2, and every hour x 3.
Monitored for 6 hours for infusion related toxicity. Temperature, blood pressure, pulse and O2 saturation will be measured at baseline and every 10 minutes x 2, every 30 minutes x 2, and every hour x 3.

Sekundære resultatmål

Resultatmål
Tidsramme
Complete and partial resolution of graft-vs-host disease (GVHD)
Tidsramme: Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.
Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.
Cytokine levels, lymphocyte subsets, and donor-reactive lymphocyte numbers in patients with acute GVHD
Tidsramme: Pre-transplant, at diagnosis, 7 and 14 days after MSC infusion
Pre-transplant, at diagnosis, 7 and 14 days after MSC infusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Case Comprehensive Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Hillard M. Lazarus, MD, Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2004

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

3. august 2006

Først indsendt, der opfyldte QC-kriterier

3. august 2006

Først opslået (Skøn)

7. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. november 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2010

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CWRU3Y03
  • P30CA043703 (U.S. NIH-bevilling/kontrakt)
  • CASE-CWRU-3Y03 (Anden identifikator: Case Comprehensive Cancer Center)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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