Clinical trial · Interventional
Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
A Phase II Trial of Bendamustine in Combination With Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to learn about the safety of the treatment with a combination of bendamustine and rituximab and to find out what effects, both good and bad this treatment has on DLBCL. In addition to learning about the combination of bendamustine and rituximab, the researchers are interested in learning about how this cancer treatment affects daily activities. Subjects will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. GAs are also designed to help the health care team understand how well subjects can carry out their day to day activities and to briefly describe what other medical conditions subjects may have. This assessment will help the health care team understand a subject's "functional age" (the age a subject functions at) as compared to a subject's actual age. The researchers also want to learn how chemotherapy affects the aging process in our bodies. This is done by measuring the amount of p16 in blood. Researchers want to understand if chemotherapy changes the levels of p16 in blood.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Diffuse Large-Cell Lymphoma | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Diffuse Large-Cell | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine, Rituximab
- description
- This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
- interventionNames
- Drug: Bendamustine
- Drug: Rituximab
Primary outcomes (1)
- measure
- Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria
- timeFrame
- 2 years
- description
- Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with previously untreated , histologically confirmed, diffuse large B-cell lymphoma (DLBCL), immunophenotyped for CD20 * Age greater than or equal to 65 years * Stage II-IV * Measurable disease including lesions that can be accurately measured in 2 dimensions by CT and have a greatest transverse diameter of 1cm or greater, and/or by bone marrow histopathology. * ECOG performance status of 0-3 * Deemed poor candidate for CHOP-R due to ejection fraction less than or equal to 45%, ECOG performance status of 2, or in the opinion of the treating physician, patient would not tolerate administration of CHOP-R chemotherapy for other reasons, * Life expectancy of at least 3 months; * Documented negative serologic testing for HIV, Hepatitis B (unless positive due to prior vaccination), and hepatitis C within the year prior to enrollment * Adequate bone marrow function (without transfusion support within one week of screening) function: * Hemoglobin \> 8 g/dL * Absolute neutrophil count (ANC) \>1000 cells/mm3 * Platelet count \> 75,000/mm3 * Adequate hepatic and renal function as demonstrated by: * Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN) * Total serum bilirubin \< 2.5 x ULN * Serum creatinine \< 1.5 x ULN * If sexually active male of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of all follow-up study visits * Signed an institutional review board (IRB) approved informed consent document Exclusion Criteria: * Central nervous system involvement by lymphoma * History of previous allergic reactions to compounds of similar biological or chemical composition as rituximab or bendamustine * Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective. * Other active malignancies (except: non-melanoma skin cancer, cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer) * Patients on strong inhibitors of CYP1A2.
References
Publications (0)
Data not yet available