Clinical trial · Interventional

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

NCT00109031CI-TRIAL-00015611completedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Etoposide	Drug	Etoposide	ALIAS
palifermin	Drug	—	UNRESOLVED
Placebo	Drug	—	UNRESOLVED
Total Body Irradiation	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
ACTIVE_COMPARATOR
label
Palifermin 60 µg/kg for 3 days
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.
interventionNames
1. Drug: palifermin
2. Radiation: Total Body Irradiation
3. Drug: Cyclophosphamide
4. Drug: Etoposide
5. Drug: Placebo
type
EXPERIMENTAL
label
Palifermin 180 μg/kg on Day -1
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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)

References

Publications (0)

Data not yet available

No reference posted for this study.