Clinical trial · Interventional
Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
NCT01010568CI-TRIAL-00020210terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to accrue patients due to change in standard CLL therapy
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ofatumumab and Bendamustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ofatumumab and Bendamustine
- description
- Ofatumumab and Bendamustine
- interventionNames
- Drug: Ofatumumab and Bendamustine
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 6 months
- description
- 40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Secondary outcomes (2)
- measure
- Complete Response Rate
- timeFrame
- 6 months
- description
- NCI IWG response criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed CLL or SLL requiring therapy * Age 18 years of age or older * ECOG performance status 0, 1, or 2 * Normal organ and bone marrow function * Resolution of toxic effects from prior therapies * Ability to adhere to the study schedule and give written informed consent Exclusion Criteria: * Any serious medical, psychiatric illness or laboratory abnormality * Chemotherapy or radiotherapy within 4 weeks of entering the study * Currently receiving other treatment for CLL/SLL or other malignancies * Active other malignancies * History of allergic reactions to bendamustine or ofatumumab * Ongoing corticosteroid use * Pregnant or lactating * HIV positive * Active hepatitis B * Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
References
Publications (1)
- DERIVEDUjjani C, Ramzi P, Gehan E, Wang H, Wang Y, Cheson BD. Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2015 Apr;56(4):915-20. doi: 10.3109/10428194.2014.933217. Epub 2014 Aug 6. PMID 24925211