Completed PHASE3 INTERVENTIONAL 4-arm NCT00109031

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

Sponsor: Amgen

Conditions Cancer Leukemia Lymphoma

Interventions Cyclophosphamide Etoposide Placebo Total Body Irradiation palifermin

Updated 6 times since 2017 Last updated: Sep 12, 2014 Started: Jan 31, 2005 Primary completion: Feb 28, 2006 Completion: Dec 31, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00109031, this PHASE3 trial focuses on Cancer and Leukemia and remains completed. Sponsored by Amgen, it has been updated 6 times since 2005, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jan 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Amgen
Swedish Orphan Biovitrum

Data source: Swedish Orphan Biovitrum

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.