Trials / Completed
CompletedNCT01002755
Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and ofatumumab may work better in treating participants with chronic lymphocytic leukemia or small lymphocytic lymphoma
Detailed description
PRIMARY OBJECTIVES: I. To evaluate efficacy and tolerability of the combination of ofatumumab and lenalidomide in patients with recurrent chronic lymphocytic leukemia (CLL). OUTLINE: Participants receive ofatumumab intravenously (IV) over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide orally (PO) daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 6 months, then every 3 months thereafter.
Conditions
- Chronic Lymphocytic Leukemia
- Fatigue
- Fever
- Hypogammaglobulinemia
- Lymphadenopathy
- Lymphocytosis
- Night Sweats
- Paraproteinemia
- Small Lymphocytic Lymphoma
- Thrombocytopenia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenalidomide | Given PO |
| BIOLOGICAL | Ofatumumab | Given IV |
Timeline
- Start date
- 2010-01-19
- Primary completion
- 2018-01-31
- Completion
- 2018-01-31
- First posted
- 2009-10-27
- Last updated
- 2019-05-07
- Results posted
- 2019-05-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01002755. Inclusion in this directory is not an endorsement.