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

Sobi

Status and phase: Completed; Phase 3

Conditions: Lymphoma; Cancer; Leukemia

Treatments: Drug: Placebo; Drug: Etoposide; Drug: palifermin; Drug: Cyclophosphamide; Radiation: Total Body Irradiation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00109031

20040212

Details and patient eligibility

About

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).

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 4 patient groups

Palifermin 60 µg/kg for 3 days

Active Comparator group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Radiation: Total Body Irradiation

Drug: palifermin

Drug: Etoposide

Drug: Placebo

Palifermin 180 μg/kg on Day -1

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Radiation: Total Body Irradiation

Drug: palifermin

Drug: Etoposide

Drug: Placebo

Palifermin 180 μg/kg on Day -2

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Radiation: Total Body Irradiation

Drug: palifermin

Drug: Etoposide

Drug: Placebo

Palifermin 180 μg/kg on Day -3

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide

Radiation: Total Body Irradiation

Drug: palifermin

Drug: Etoposide

Drug: Placebo