Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Rare Diseases

Lymphoma

Leukemia

Hematologic Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Etoposide

Cyclophosphamide

Etoposide phosphate

Mitogens

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

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.

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.

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.

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.

Administered as one daily intravenous bolus.

palifermin

To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.

Total Body Irradiation

Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2

Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.

Placebo

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).

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

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

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.

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.

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.

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.

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.

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.

Amgen

Swedish Orphan Biovitrum

Seven participants received the wrong sequence of placebo and palifermin as follows (# participants \[from assigned arm to actual treatment arm\]): 2 participants (A to C), 2 participants (D to B), 1 participant (C to A), 1 participant (B to D), 1 participant (C to D). Adverse event data are summarized by actual treatment group.

Palifermin 60 µg/kg 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).

Palifermin 60 µg/kg for 3 Days (A)

Palifermin 180 μg/kg on Day -1 and placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.

Palifermin 180 μg/kg on Day -1 (B)

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.

Palifermin 180 μg/kg on Day -2 (C)

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.

Palifermin 180 μg/kg on Day -3 (D)

Palifermin 60 µg/kg for 3 Days

Palifermin 180 μg/kg on Day -1

Palifermin 180 μg/kg on Day -2

Palifermin 180 μg/kg on Day -3

Total

Age, Continuous

Sex: Female, Male

White or Caucasian

Black or African American

Hispanic or Latino

Race/Ethnicity, Customized

Hodgkin's disease

Non-Hodgkin's lymphoma

Multiple Myeloma

Acute lymphoblastic leukemia

Acute myelogenous leukemia

Chronic lymphocytic leukemia

Chronic myelogenous leukemia

Acute lymphoblastic leukemia., Acute myelogenous leukemia, Chronic lymphocytic leukemia, and1 ( 8) Chronic myelogenous leukemia are subsets of Leukemia.

Type of diagnosis

Etoposide use

≤ 2 days

3 days

4 days

≥ 5 days

Data are reported for the safety analysis set, as treated. Seven participants received the wrong sequence of placebo and palifermin in error in. Consequently, 10, 11, 13, and 12 participants actually received treatment according in each treatment arm respectively.

Number of days of total body irradiation

Primary Analysis Set (all randomized participants who signed informed consent before invasive, protocol-specified procedures).

Spots Global Cancer Trial Database for Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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