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

12. September 2014 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

47

Phase

  • Phase 3

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Arzneimittel: palifermin
Administered as one daily intravenous bolus.
Andere Namen:
  • Erhaltung
  • Rekombinanter menschlicher Keratinozyten-Wachstumsfaktor (rHuKGF)
Strahlung: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Arzneimittel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Arzneimittel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andere Namen:
  • VP-16
Arzneimittel: Placebo
Administered as one daily intravenous bolus.
Experimental: 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.
Arzneimittel: palifermin
Administered as one daily intravenous bolus.
Andere Namen:
  • Erhaltung
  • Rekombinanter menschlicher Keratinozyten-Wachstumsfaktor (rHuKGF)
Strahlung: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Arzneimittel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Arzneimittel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andere Namen:
  • VP-16
Arzneimittel: Placebo
Administered as one daily intravenous bolus.
Experimental: 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.
Arzneimittel: palifermin
Administered as one daily intravenous bolus.
Andere Namen:
  • Erhaltung
  • Rekombinanter menschlicher Keratinozyten-Wachstumsfaktor (rHuKGF)
Strahlung: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Arzneimittel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Arzneimittel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andere Namen:
  • VP-16
Arzneimittel: Placebo
Administered as one daily intravenous bolus.
Experimental: 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.
Arzneimittel: palifermin
Administered as one daily intravenous bolus.
Andere Namen:
  • Erhaltung
  • Rekombinanter menschlicher Keratinozyten-Wachstumsfaktor (rHuKGF)
Strahlung: Total Body Irradiation
To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.
Arzneimittel: Cyclophosphamide
Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2
Arzneimittel: Etoposide
Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.
Andere Namen:
  • VP-16
Arzneimittel: Placebo
Administered as one daily intravenous bolus.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Swedish Orphan Biovitrum

Mitarbeiter

Amgen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2005

Primärer Abschluss (Tatsächlich)

1. Februar 2006

Studienabschluss (Tatsächlich)

1. Dezember 2010

Studienanmeldedaten

Zuerst eingereicht

22. April 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2005

Zuerst gepostet (Schätzen)

25. April 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. September 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. September 2014

Zuletzt verifiziert

1. September 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20040212

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