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Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

12. september 2014 oppdatert av: Swedish Orphan Biovitrum

A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization [WHO] grade 3 and 4).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

47

Fase

  • Fase 3

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent
  • Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
  • Minimum of 1.5 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.

Exclusion Criteria:

  • Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
  • Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
  • Congestive heart failure as defined by New York Heart Association class III or IV.
  • History of or current diagnosis of pancreatitis
  • Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
  • Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or alanine aminotransferase (ALT) greater than 3x upper limit of normal per the institutional guidelines)
  • Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon monoxide (DLCO) less than 50% of predicted.
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Palifermin 60 µg/kg for 3 days
Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Legemiddel: palifermin
Administered as one daily intravenous bolus.
Andre navn:
  • Kepivance
  • Rekombinant human keratinocyttvekstfaktor (rHuKGF)
Stråling: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Legemiddel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Legemiddel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andre navn:
  • VP-16
Legemiddel: Placebo
Administered as one daily intravenous bolus.
Eksperimentell: Palifermin 180 μg/kg on Day -1
Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Legemiddel: palifermin
Administered as one daily intravenous bolus.
Andre navn:
  • Kepivance
  • Rekombinant human keratinocyttvekstfaktor (rHuKGF)
Stråling: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Legemiddel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Legemiddel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andre navn:
  • VP-16
Legemiddel: Placebo
Administered as one daily intravenous bolus.
Eksperimentell: Palifermin 180 μg/kg on Day -2
Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Legemiddel: palifermin
Administered as one daily intravenous bolus.
Andre navn:
  • Kepivance
  • Rekombinant human keratinocyttvekstfaktor (rHuKGF)
Stråling: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Legemiddel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Legemiddel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andre navn:
  • VP-16
Legemiddel: Placebo
Administered as one daily intravenous bolus.
Eksperimentell: Palifermin 180 μg/kg on Day -3
Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Legemiddel: palifermin
Administered as one daily intravenous bolus.
Andre navn:
  • Kepivance
  • Rekombinant human keratinocyttvekstfaktor (rHuKGF)
Stråling: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Legemiddel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Legemiddel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andre navn:
  • VP-16
Legemiddel: Placebo
Administered as one daily intravenous bolus.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)
Tidsramme: Up to Day 28
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Up to Day 28

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
Tidsramme: Up to Day 28
The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.
Up to Day 28
Area Under the Curve (AUC) of Mouth and Throat Soreness Score
Tidsramme: From the first day of study drug administration through Day 28
The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS.
From the first day of study drug administration through Day 28
Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
Tidsramme: Up to Day 28
Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.
Up to Day 28
Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis
Tidsramme: Up to Day 28
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Up to Day 28
Duration of WHO Grade 2, 3 or 4 Oral Mucositis
Tidsramme: Up to Day 28

The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study.

OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Up to Day 28
Number of Participants With WHO Grade 4 Oral Mucositis
Tidsramme: Up to Day 28
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
Up to Day 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Swedish Orphan Biovitrum

Samarbeidspartnere

Amgen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2005

Primær fullføring (Faktiske)

1. februar 2006

Studiet fullført (Faktiske)

1. desember 2010

Datoer for studieregistrering

Først innsendt

22. april 2005

Først innsendt som oppfylte QC-kriteriene

22. april 2005

Først lagt ut (Anslag)

25. april 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20040212

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