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Reduced Intensity Double Umbilical Cord Blood Transplantation

29. december 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

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
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital

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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

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
Eksperimentel: Fludarabine/Melphalan/TBI
All patients receive same therapy
Medicin: Fludarabine
30 mg/m2/day IV x 6 days
Andre navne:
  • Fludara
Medicin: Melphalan
100 mg/m2/dag IV x 1 dag
Stråling: Total Body Radiation
200 cGy on Day 0
Biologisk: Cord Blood
2 cord blood units IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With a Clinically Significant Infection
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Median Time to Neutrophil Engraftment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 Year
1 Year
Relapse-free Survival
Tidsramme: 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
Tidsramme: 2 years
The percentage of participants alive at two years
2 years
1 Year Relapse Rate
Tidsramme: 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
Tidsramme: 2.5 years
The number of participants that were found to have lymphoma post-transplant.
2.5 years
Median Thrombopoietin Levels After Transplant
Tidsramme: 30 Days
30 Days

Samarbejdspartnere og efterforskere

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

Sponsor

Massachusetts General Hospital

Efterforskere

  • Ledende efterforsker: Zachariah DeFilipp, MD, Massachusetts General Hospital

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 2011

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

2. august 2011

Først indsendt, der opfyldte QC-kriterier

2. august 2011

Først opslået (Skøn)

3. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11-085

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