Clinical trial · Interventional
Bendamustine-based Combination Therapy for PCNSL
Plasma and Cerebrospinal Fluid (CSF) Pharmacokinetics of Bendamustine as a Component of Salvage Therapy for Primary Central Nervous System Lymphoma (PCNSL)
NCT03392714CI-TRIAL-00031055unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This pilot study will i) evaluate the efficacy and the safety of bendamustine-based combination chemotherapy and ii) investigate the pharmacokinetics (PK)of bendamustine in plasma and CSF when given as salvage treatment for patients with relapsed or refractory primary central nervous system lymphoma (PCNSL).
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 |
|---|---|---|---|
| PCNSL | Primary Central Nervous System Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-B(O)AD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-B(O)AD
- description
- Intravenous R-B(O)AD every 4 weeks for up to 4 cycles
- interventionNames
- Drug: R-B(O)AD
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- 2 year
- description
- rate of complete or partial response (CR/PR)
Secondary outcomes (5)
- measure
- Toxicity based on NCI Common Terminology Criteria version 4.0
- timeFrame
- 2 year
- description
- adverse event incidence of combination regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. PCNSL of diffuse large B-cell lymphoma (DLBCL) with a CNS lesion by tissue biopsy 2. Age ≥ 19 years old 3. Relapsed or refractory PCNSL after frontline combined chemotherapy or radiation 4. ECOG performance status 0-2 5. Absolute neutrophil count ≥ 1000/uL 6. Platelets ≥ 100,000/uL 7. Total bilirubin ≤ 1.5 x ULN (upper limit of normal) 8. Aspartate aminotransferase (AST) ≤ 3 x ULN 9. Creatinine ≤ 2.0 x ULN Exclusion Criteria: 1. PCNSL of other than DLBCL or T-cell lymphoma with a CNS lesion by tissue biopsy 2. Any of the following: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception 3. Uncontrolled infection 4. Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration 5. Persistent toxicities ≥ grade 3 from prior chemotherapy or biologic therapy regardless of interval since last treatment 6. History of thromboembolic episodes ≤ 3 months prior to registration 7. Active hepatitis B or C with uncontrolled disease 8. Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment 9. Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study 10. Major surgery ≤ 4 weeks prior to registration or have not recovered from side effects of such therapy
References
Publications (1)
- DERIVEDKim T, Choi HY, Lee HS, Jung SH, Ahn JS, Kim HJ, Lee JJ, Yoo HD, Yang DH. Clinical response and pharmacokinetics of bendamustine as a component of salvage R-B(O)AD therapy for the treatment of primary central nervous system lymphoma (PCNSL). BMC Cancer. 2018 Jul 9;18(1):729. doi: 10.1186/s12885-018-4632-y. PMID 29986691