Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
CLL, SLL, Bendamustine, Ofatumumab
Brief summary
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.
Interventions
DRUGOfatumumab and Bendamustine
Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles
Sponsors
Georgetown University
GlaxoSmithKline
Cephalon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 6 months | 40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | 6 months | NCI IWG response criteria |
| Median PFS | 2 years | Kaplan Meyer PFS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ofatumumab and Bendamustine Ofatumumab and Bendamustine
Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Ofatumumab and Bendamustine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 63 years |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 3 / 10 |
Outcome results
Primary
Overall Response Rate
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ofatumumab and Bendamustine | Overall Response Rate | 4 participants |
Secondary
Complete Response Rate
NCI IWG response criteria
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ofatumumab and Bendamustine | Complete Response Rate | 2 participants |
Secondary
Median PFS
Kaplan Meyer PFS
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ofatumumab and Bendamustine | Median PFS | 8.1 months |