Status:
COMPLETED
Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied.
Detailed Description
The Study Drug: Ofatumumab is designed to bind to the surface of some of the white blood cells (B-cells). It may destroy cancer cells that come from B-cells. Study Drug Administration: If you are f...
Eligibility Criteria
Inclusion
- Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL), previously untreated, Rai stage 0-ll
- At least 1 of the following high-risk features for previously untreated patients: Rai stage II disease; Rai stage 0-I with disease-related fatigue; Serum beta2M \>/= 3 mg/L; Absolute lymphocyte count \>/= 25,000/uL; Unmutated IGHV gene or IGHV3-21; ZAP70 positive (\>/= 20% by flow cytometry or positive by immunohistochemistry); CD38 positive (\>/= 30% by flow cytometry); OR Deletion 11q or 17p by FISH
- ECOG PS \</= 2
- Age \>/= 18 years
- Patients must have adequate renal and hepatic function (creatinine \<2mg/dL, total bilirubin \<2mg/dL). Patients with renal or liver dysfunction due to organ infiltration with CLL may be eligible after discussion with the study chairman
- Provide informed consent
- Female patients (including those \< 1 year post-menopausal) and male patients who have not undergone previous surgical sterilization must agree to use contraception.
Exclusion
- Presence of 2008 IWCLL/NCI-WG indication for CLL treatment: Constitutional symptoms related to CLL/SLL: Fever \> 100.5 degrees F for \>/= 2 weeks or night sweats for \> 1 mo, both without evidence of infection; Unintentional weight loss of \>/= 10% body weight in previous 6 months; Extreme fatigue (ECOG PS \> 2; inability to work or perform usual activities); Lymphocyte doubling time of \</= 6 months or 50% increase in absolute lymphocyte count within 2 months; Progressive anemia (Rai stage III) or thrombocytopenia (Rai stage IV); Recurrent infections unrelated to hypogammaglobulinemia; Autoimmune phenomenon poorly responsive to corticosteroids or other standard therapy; Massive, progressive or symptomatic lymphadenopathy (\> 10 cm in longest diameter) or splenomegaly (\> 6 cm below left costal margin)
- Prior or concurrent chemotherapy, radiotherapy, or immunotherapy for CLL
- Active infection (febrile and requiring IV/PO antibiotics), including hepatitis C or HIV, or significant medical illness including renal, cardiac, pulmonary disease, or current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Positive serology for Hepatitis B virus (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the patient will be excluded. -- Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HB positive.
- Pregnant or breast feeding females are not eligible.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01243190
Start Date
March 1 2011
End Date
March 28 2023
Last Update
September 19 2024
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030