Clinical trial · Interventional
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
A Phase I/II Clinical Trial of Fludarabine, Bendamustine, and Rituximab (FBR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)
- 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 goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1 20 mg/m^2
- description
- Bendamustine, Fludarabine + Rituximab
- interventionNames
- Drug: Bendamustine
- Drug: Fludarabine
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Phase 2
- description
- Bendamustine 30 mg/m\^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab
- interventionNames
- Drug: Bendamustine
- Drug: Fludarabine
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Phase 1 30 mg/m^2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have a diagnosis of CLL/Small Lymphocytic Lymphoma (SLL) and be previously treated 2. Patients must have an indication for treatment by 2008 IWCLL Criteria 3. Age \>/= 16 years 4. Zubrod performance status \</= 2 5. Adequate renal and hepatic function as indicated by all the following: a. serum creatinine \</= 2 mg/dL AND; b. alanine aminotransferase (ALT) \</= 2.5 times upper limit of normal AND; c. total bilirubin \</= 2.5 times upper limit of normal 6. Patients must give written informed consent 7. Patients of childbearing potential must be willing to practice birth control during the study Exclusion Criteria: 1. Pregnant or breast-feeding females 2. Significant co-morbidity indicated by major organ system dysfunction 3. Active, uncontrolled infection, including active hepatitis 4. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia purpura (ITP) 5. Treatment including chemotherapy, chemoimmunotherapy, monoclonal antibody therapy, radiotherapy, high-dose corticosteroid therapy (Prednisone \>/ 60 mg daily or equivalent), or immunotherapy within 21 days prior to enrollment or concurrent with this trial
References
Publications (0)
Data not yet available