Assessment of the inflammation of oral mucosa in lymphoma patients receiving Palifermin after high-dose conditioning with BEAM and autologous peripheral blood stem cell transplantatio

Phase 4

• Conditions: C81; C83; Follicular lymphoma; C82; C85; C84; Hodgkin lymphoma; Non-follicular lymphoma; Mature T/NK-cell lymphomas; C88

• Registration Number: DRKS00000043
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-06
• Study Completion: 2011-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

primary high-grade lymphoma
> 2 risk factors according to IPI
refractory NHL/Hodgkin
all Burkitt's lymphoma (<30% bone marrow infiltration)
all chemotherapy sensitiv NHL- and Hodgkin-relapse
KI >60%
Life expectancy > 3 months

Exclusion Criteria

known CNS involvement
HIV disease or immunologic deficiency
severe concomitant disease
severe psychiatric illness
prior therapy with palifermin
hypersensitivity to one of the trial drugs
pregnancy, lactation, positive pregnancy test

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe oral mucositis (WHO grade 3/4)<br>Incidence of severe oral mucositis (WHO grade 3/4) whithin 30 days after autologous PBSCT

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: comparison of Palifermin and Best Supportive Care in regard to secondary targets:<br>•Duration of a severe oral mucositis (WHO grade 3/4)<br>•Time span to the beginning of a severe oral mucositis<br>•Incidence, duration and time to the development of an oral mucositis grade 2, 3, or 4<br>•Incidence and duration of a febrile neutropenia (leukocytes <1000/µl and body temperature >38,5C°)<br>•Consumption of opioid analgesics (frequency, total dose, time period)<br>•Incidence and duration of complete parenteral nutrition<br>