Lenalidomide and Obinutuzumab for Previously Untreated CLL
Withdrawn before enrolling · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia
In brief
This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this setting and induce complete clinical responses.
Key facts
- Study ID
- NCT02371590
- Run by
- University of California, San Diego
- People needed
- 0
- Starts
- 2018-02-01
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2018-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Women for child-bearing age must obtain a pregnancy test and pregnant or breast feeding females are excluded.
- Known hypersensitivity to thalidomide or lenalidomide (if applicable), including development of erythema nodosum or a desquamating rash while taking thalidomide or similar drugs.
- Deep vein thrombosis or superficial thrombophlebitis of any cause on current anticoagulation therapy at the time of screening.
- Patients who are currently receiving another investigational agent are excluded.
- Current infection requiring parenteral antibiotics.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV); or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) based on detectable viral load. Patients who are seropositive because of hepatitis B virus vaccine or passive immunization by intravenous immunoglobulin (IVIG) are eligible.
- Active malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ).
- Known central nervous system (CNS) involvement by malignancy.
- Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
- Insufficient recovery from surgical-related trauma or wound healing.
- Impaired cardiac function
Where it is running
- UC San Diego Moores Cancer Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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