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Efficacy Study of a TXA127 to Reduce Graft-vs-Host Disease in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

29. august 2016 opdateret af: Tarix Pharmaceuticals

Phase II Evaluation of the Efficacy of TXA127 (Angiotensin 1-7) to Reduce Acute Graft-vs.-Host Disease in Adults Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing allogeneic peripheral blood stem cell transplantation (PBSCT). The study will also evaluate the effects of TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet recovery; platelet transfusion requirements; immune reconstitution; and duration of corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce rapid production of neutrophils and platelets in the bloodstream, as well as increase the immune system components. TXA127 has also been shown reduce the severity of chemotherapy-induced mucositis.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Allogeneic hematopoietic stem cell transplantation (HSCT) is increasingly used as an effective treatment for malignant disease. The three most common sources for stem cells used in HSCT are bone marrow (BM), umbilical cord blood (UCB), and peripheral blood stem cells (PBSC). In a retrospective review of 1,525 adults with acute leukemia receiving allogeneic transplants between 2002 and 2006, UCB accounted for 10.8%, PBSC for 58.2%, and BM for 31% of the population (Eapen et al., 2010). PBSC as a source of hematopoietic stem cells for transplantation has advantages over bone marrow in terms of donation ease and comfort and over cord blood in terms of adequate cell dose. However, PBSC transplantations are associated with an increased incidence of graft-versus-host disease (GVHD). Based on current literature acute GVHD (aGVHD) is reported in 48-80% of PBSCT recipients (Eapen et al., 2010, Ferrara et al., 2009). Additionally, the myeloablative conditioning regimens used for these transplants often result in mucositis which can be debilitating to patients. TXA127 is pharmaceutically-formulated angiotensin 1-7, a non-hypertensive derivative of angiotensin II. TXA127 has multilineage effects on hematopoietic progenitors in vitro and in vivo. The hematopoietic properties demonstrated in preclinical and clinical studies support the investigation of TXA127 to reduce the incidence of aGVHD and mucositis in this patient population.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Winship Cancer Institute, Emory University
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer 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

Inclusion Criteria:

  • Provided written informed consent.
  • ≥18 years of age.
  • Meet institutional standard criteria for PBSC transplantation
  • Myeloablative conditioning regimen
  • Histologically confirmed diagnosis of a hematologic malignancy.
  • Life expectancy of >4 months.
  • Female subjects capable of reproduction (defined as a subject who has started menses) must agree to the following: 1) Use of an effective oral or IM contraceptive method during the course of the study and 2 months following the last administration of Investigational Product; and 2) must have a negative pregnancy test result within 7 days prior to first Investigational Product dose.

Exclusion Criteria:

  • Uncontrolled infection at the time of transplant.
  • Pregnant or breastfeeding.
  • Known to be seropositive for HIV or HTLV-1.
  • Active CNS disease at the time of study enrollment.
  • Treatment with an investigational agent within 30 days of anticipated administration of the first dose of Investigational Product.
  • Current alcohol use, illicit drug use or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule.
  • Any co-morbid condition which, in the view of the Principal Investigators, renders the subject at too high a risk from treatment complications and regimen-related morbidity/mortality.
  • Prophylactic treatment with palifermin for mucositis.
  • Subjects with a known sensitivity to any of the Investigational Product components.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TXA127, blood draws, physical exams
Single-arm safety/efficacy trial of TXA127 (Angiotensin 1-7) in subjects undergoing allogeneic peripheral blood stem cell transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect. Treatment dose is 300 mcg/kg/day TXA127.
Medicin: TXA127
Injektion, 300mcg/kg/dag i 28 dage

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst af grad II-IV akut graft-vs-host-sygdom (aGVHD)
Tidsramme: 100 dage efter transplantationen
Forekomsten af ​​grad II-IV akut graft-vs-værtssygdom (aGVHD) vil blive vurderet ved hjælp af kliniske stadie- og klassificeringskriterier som defineret i Przepiorka et al. (1995). Varighed og sværhedsgrad af aGVHD vil også blive evalueret.
100 dage efter transplantationen

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Krav til blodpladetransfusion
Tidsramme: 100 dage efter transplantationen
Kravene til blodpladetransfusion er baseret på kumulative enheder af blodpladetransfusioner og kumulative dage med blodpladetransfusioner.
100 dage efter transplantationen
Immunrekonstitution
Tidsramme: 100 dage efter transplantationen
Immunrekonstitution vil blive vurderet via måling af perifere blodkoncentrationer af CD3+-, CD4+-, CD8+-, CD19+- og CD56+-celler (udført på studiedage 62 og 100).
100 dage efter transplantationen
Varighed af kortikosteroidbrug
Tidsramme: 100 dage efter transplantationen
Varigheden af ​​kortikosteroidbrug til GVHD vil blive opsummeret efter hyppighed (dvs. antal dage).
100 dage efter transplantationen
Incidence, duration, and severity grade of mucositis
Tidsramme: 100 days post-transplantation
Incidence of mucositis is defined by the occurrence of least one adverse event with MedDRA preferred term that includes "mucositis" or "stomatitis". The severity grade will be determined by NCI-CTCAE.
100 days post-transplantation
Neutrophil engraftment and platelet recovery
Tidsramme: 100 days post-transplantation
Time to initial neutrophil engraftment is defined as the number of days from PBSC transplant to the first of 3 consecutive days of an ANC ≥0.5 × 10^9/L. Time to initial platelet recovery is defined as the number of days from PBSC transplant to the first of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10^9/L with no platelet transfusion in the prior 7 days.
100 days post-transplantation

Samarbejdspartnere og efterforskere

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

Sponsor

Tarix Pharmaceuticals

Efterforskere

  • Ledende efterforsker: Edmund K Waller, MD,PhD,FACP, Emory University

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. december 2013

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

17. juni 2013

Først indsendt, der opfyldte QC-kriterier

17. juni 2013

Først opslået (Skøn)

20. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TXA127-2012-02

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 .

Kliniske forsøg med TXA127

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Betingelser

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