Chronic Lymphocytic LeukemiaPhase 2NCT01010568
Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Ofatumumab and Bendamustine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Ofatumumab and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnant or lactating
- HIV positive
- Active hepatitis B
- Allogeneic transplant within 6 months of entering study or graft-versus-host disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
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.
- Being tested
- Ofatumumab and Bendamustine
- Keywords
- CLL, SLL, Bendamustine, Ofatumumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ofatumumab and BendamustineDrug
Also called Bendamustine, Treanda, Ofatumumab
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
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab and Bendamustine | Experimental | Ofatumumab and Bendamustine Receives: Drug: Ofatumumab and Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Measured: 6 months
Secondary outcomes (2)
Complete Response Rate
NCI IWG response criteria
Measured: 6 months
Median PFS
Kaplan Meyer PFS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startApr 2010
- Primary completionMay 2014
- Study completionAug 2014
Why it stopped: Unable to accrue patients due to change in standard CLL therapy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Cephalon
- Responsible party
- Sponsor
- Investigators
- Bruce Cheson, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010568
- Sponsor's protocol ID
- OB2009-315
- Status last verified
- Sep 2015
- First submitted
- 19 Oct 2009
- Last updated
- 15 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ujjani 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.
PubMed 24925211
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia/ Small Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01010568
- Acronym / sponsor ID
- OB2009-315
- Keywords
- CLL, SLL, Bendamustine, Ofatumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to accrue patients due to change in standard CLL therapy
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Cephalon
- Study start
- Apr 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 15 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab and Bendamustine | Experimental | Drug: Ofatumumab and BendamustineOfatumumab and Bendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ofatumumab and BendamustineAlso: Bendamustine, Treanda, OfatumumabOfatumumab 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 | Drug | Ofatumumab and Bendamustine |
Primary outcome
Overall Response Rate
Time frame: 6 months
40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
2 secondary outcomes
Complete Response Rate
Time frame: 6 months
Median PFS
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24925211Ujjani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Cheson, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ofatumumab and Bendamustine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.