Malignant lymphoma C85.7 C91.1 C90.0
Conditions
Interventions
Group 1: Treatment with bendamustine according to the SmPC in the context of an observational study.
Collection of demographic and medical history data, health status, dosage and regimen, concomitant
Sponsors
AxioNovo Gmbh
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Signed and dated consent exists. - The patient has a histologically or cytologically secured malignant lymphoma. - The therapy decision was made independently of a possible study inclusion. - Patient is at least 18 years old
Exclusion criteria
Exclusion criteria: - Hypersensitivity to the active substance bendamustine hydrochloride or mannitol - Breastfeeding, pregnancy or planned pregnancy - Severe hepatic impairment (serum bilirubin> 3.0 mg / dL) - Jaundice - Severe bone marrow suppression and severe alteration of the blood count (leukocyte or platelet decreases to <3,000 / µL or <75,000 / µL) - Larger surgical procedures within 30 days before the start of treatment - Infections, especially in connection with leukocytopenia - Yellow fever vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Efficacy: Was the therapy with Bendamustine LIV completed within the planned therapy time? What are the reasons for discontinuation? Clinical outcome of therapy, at the end of therapy and follow-up time points after 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Tolerability: incidence of unexpected side effects throughout the study. Need for and extent of supportive, anti-infective concomitant therapies during therapy. - Quality of life: Quality of life assessed by FACT-Leu_Ver4_NI_10Aug12, FACT-Lym_Ver4_NI_10Aug12, and FACT-MM_Ver4_NI_20Jan17 at therapy initiation, therapy completion, and follow-up at 6 and 12 months. | — |
Countries
Germany
Contacts
Public ContactBurkard Heckelbacher
Datafaber GbR
Outcome results
None listed