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Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies

22. juni 2017 opdateret af: Racquel Innis-Shelton, MD, University of Alabama at Birmingham

UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies

A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35249-6979
        • University of Alabama in Birmingham BMT/CT Program Outpatient Clinic

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

19 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Stage II or III non-progressive disease Multiple Myeloma.
  • CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
  • ≤ 70 years old.
  • Eligible and willing HLA matched related donor.
  • Bilirubin <2xULN.
  • ALT and AST <3xULN.
  • LVEF > 40%.
  • Creatinine Clearance >40mL/min.
  • Pulmonary function DLCO corrected to ≥ 70%.
  • Minimum performance score of 70%.
  • Platelet count >130 x103 micro L.
  • LDH ≤1.5xULN.
  • No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
  • No uncontrolled infections.

Exclusion Criteria:

  • Age >70 years old.
  • Performance status <70%.
  • Uncontrolled infections or is HIV positive
  • Prior malignancies that are felt to have a <80% probability of being cured.
  • Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
  • Prior Allograft
  • History of rapidly growing disease at diagnosis or at any progression or have MDS.
  • No eligible and willing HLA matched donor.

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)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Non Myeloablative Treatment

Non-myeloablative Transplant Conditioning Chemotherapy :

Fludarabine - 30 mg/m2/day x 3 days Total Body Irradiation - 200cGy x1 dose Infusion of Stem Cells - On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.
Medicin: Fludarabine
Fludarabine 30 mg/m2/day x 3 days
Stråling: Total Body Irradiation
TBI 200cGy x1 dose on transplant day
Andet: Infusion of Stem Cells
On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressive Free Survival Post Transplant
Tidsramme: 100 days post transplant
subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
100 days post transplant
Progressive Free Survival Post Transplant
Tidsramme: 180 days post transplant
Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
180 days post transplant
Progressive Free Survival Post Transplant
Tidsramme: 365 days post transplant
Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.
365 days post transplant
Progression Free Survival Post Transplant
Tidsramme: 2 years post transplant
Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.
2 years post transplant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-relapse Treatment Related Mortality
Tidsramme: Within 100 days post transplant
Death related to treatment without relapse within 100 days after transplant
Within 100 days post transplant
Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant
Tidsramme: Post transplant up to 100 days post transplant
Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.
Post transplant up to 100 days post transplant
Composite Incidence of Acute and Chronic Graft Versus Host Disease
Tidsramme: Up to 100 days post transplant.
Up to 100 days post transplant.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Alabama at Birmingham

Efterforskere

  • Ledende efterforsker: William P. Vaughan, MD, University of Alabama in Birmingham

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. juli 2008

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

10. juli 2008

Først indsendt, der opfyldte QC-kriterier

11. juli 2008

Først opslået (Skøn)

14. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F080429003
  • UAB-0775 (Anden identifikator: UAB Cancer Center study number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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