malign lymphoma (primary high risks patients: - therapy refractory / relapsed NHL - therapy refractory / relapsed M. Hodgkin - Burkitt-NHL MedDRA version: 9.1 Level: LLT Classification code 10006595 Term: Burkitt's lymphoma MedDRA version: 9.1 Level: LLT Classification code 10029609 Term: Non-Hodgkin's lymphoma unspecified histology aggressive recurrent MedDRA version: 9.1 Level: LLT Classification code 10029610 Term: Non-Hodgkin's lymphoma unspecified histology aggressive refractory MedDRA
Conditions
Interventions
Trade Name: Kepivance 6,25 mg Pulver zur Herstellung einer Injektionslösung /
Powder for solution for injection
Pharmaceutical Form: Powder for solution for injection
Other descriptive name: PALIFERM
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: # Primary high risk lymphoma patients # >2 lesions after IPI (increased LDH, Karnofsky index = 70%, Stage III/IV, age > 60 years, = 2 extra nodal manifestations) # Therapy-refractory NHL/Hodgkin’s patients (no response to standard therapy , no CR after completion of chemotherapy, PD or SD after 3-6 weeks of chemotherapy) # All Burkitt’s lymphoma ( 60% # Life expectancy > 3 months # Legally capable patient # Written informed consent following written and oral information Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: # Primary high risk lymphoma patients # >2 lesions after IPI (increased LDH, Karnofsky index = 70%, Stage III/IV, age > 60 years, = 2 extra nodal manifestations) # Therapy-refractory NHL/Hodgkin’s patients (no response to standard therapy , no CR after completion of chemotherapy, PD or SD after 3-6 weeks of chemotherapy) # All Burkitt’s lymphoma ( 60% # Life expectancy > 3 months # Legally capable patient # Written informed consent following written and oral information Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: # Proven affection of the central nervous system (CNS) # HIV infection or immune deficiency syndrome # Other serious concomitant diseases (such as clinically relevant heart failure: NYHA III-IV, EF < 40%, serious liver or lung disease, terminal renal failure, etc.) # Severe psychological illness # Prior treatment with Palifermin # Hypersensitivity to one or several of the compounds used # Pregnancy, lactation period # Participation in another clinical trial 30 days before, during or 30 days after this trial ;Exclusion criteria: # Proven affection of the central nervous system (CNS) # HIV infection or immune deficiency syndrome # Other serious concomitant diseases (such as clinically relevant heart failure: NYHA III-IV, EF < 40%, serious liver or lung disease, terminal renal failure, etc.) # Severe psychological illness # Prior treatment with Palifermin # Hypersensitivity to one or several of the compounds used # Pregnancy, lactation period # Participation in another clinical trial 30 days before, during or 30 days after this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of best supportive care (BSC) plus palifermin versus BSC alone within thirty days after peripheral blood stem cell transplantation.;Secondary Objective: - Duration of oral mucositis (WHO grade 3/4) - Time until the begin of a severe oral mucositis - Incidence, duration and time until the begin of a oral mucositis grade 2,3 or 4 - Incidence, duration of febrile leukopenia (leukocytes 38.5°C - Usage of opioide analgesics (frequency, total dose and duration) - Incindence and duration of complete parenteral nutrition - Progression free survival rate, progressive disease (only CR patients), start of a systemic therapy - Oral survival - Evaluation of duration of response;Primary end point(s): Incidence of severe oral mucositis (WHO grade 3/4) within thirty days after PBSCT.;Main Objective: Efficacy of best supportive care (BSC) plus palifermin versus BSC alone within thirty days after peripheral blood stem cell transplantation.;Secondary Objective: - Duration of oral mucositis (WHO grade 3/4) - Time until the begin of a severe oral mucositis - Incidence, duration and time until the begin of a oral mucositis grade 2,3 or 4 - Incidence, duration of febrile leukopenia (leukocytes 38.5°C - Usage of opioide analgesics (frequency, total dose and duration) - Incindence and duration of complete parenteral nutrition - Progression free survival rate, progressive disease (only CR patients), start of a systemic therapy - Oral survival - Evaluation of duration of response;Primary end point(s): Incidence of severe oral mucositis (WHO grade 3/4) within thirty days after PBSCT. | — |
Countries
Germany
Contacts
Public Contact; ;
;
Outcome results
None listed