BENITA study on the use of bendamustine in the therapy of malignant lymphomas

• Conditions: Malignant lymphoma; C85.7; C91.1; C90.0; Other specified types of non-Hodgkin lymphoma; Chronic lymphocytic leukaemia of B-cell type; Multiple myeloma

• Registration Number: DRKS00012312
• Lead Sponsor: AxioNovo Gmbh

Brief Summary

The present study confirms the results of earlier studies by Weide and Dhalla, according to which supportive drug therapy can significantly influence the infection rate. The study shows that active or prophylactic avoidance of infections is sought in oncology practice. Older patients appear to benefit considerably from appropriate supportive therapy. Interestingly, the results suggest that the dosage of medication depends heavily on the goals of the therapy. Since the focus was not primarily on cure, but on prolonging symptom-free and progression-free periods and maintaining quality of life, lower dosages of bendamustine axios appear to be entirely justifiable and are related to the assessment of clinical tolerability by the treating physician. The availability of monoclonal antibodies also opens further treatment options that make it possible to adapt the therapy even more individually and possibly make it even more effective. The present study shows that younger patients have a better quality of life in the emotional area due to family support and an improved ability to function due to a professional perspective and a sense of purpose. These results suggest that a holistic view of quality of life is also important for older patients. To improve the quality of life of older patients, interventions could be developed that specifically aim to strengthen family ties and social support. In addition, programs could be implemented to promote a sense of purpose at work and to maintain independence in old age. A comprehensive understanding of the individual needs of older patients is crucial to developing and implementing targeted measures to improve their quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-29
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 56

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- 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 Outcome Measures

Name	Time	Method
- Tolerability: incidence of unexpected side effects throughout the study. Need for and extent of supportive, anti-infective concomitant therapies during therapy.<br>- 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.