Ofatumumab Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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.
Disease Group: Leukemia
Treatment Agent: Ofatumumab
Treatment Location: Only at MD Anderson
1. The primary objective is to determine the response rate (IWCLL/NCI-WG criteria) to treatment with single-agent ofatumumab in previously untreated, early stage, high-risk patients with CLL/SLL The secondary objectives are: 1. Determine time-to-progression in high-risk patients treated with ofatumumab. 2. Determine time-to-next chemotherapy or alternative therapy. 3. Evaluate the pharmacokinetics of single-agent ofatumumab in high-risk, previously treated patients with CLL.4. Evaluate for circulating CD20+ cells through treatment and in follow-up in high-risk patients treated with ofatumumab. 5. Evaluate safety and toxicities of ofatumumab in previously untreated high-risk patients with CLL/SLL.
IRB Review and Approval Date: 03/22/2011
Recruitment Status: Closed
Projected Accrual: N/A
1) Diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic
leukemia (SLL), previously untreated, Rai stage 0-ll
2) 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
3) ECOG PS </= 2
4) Age >/= 18 years
5) 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
6) Provide informed consent
7) Female patients (including those < 1 year post-menopausal) and male patients who have not undergone previous surgical sterilization must agree to use contraception.
1) 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)
2) Prior or concurrent chemotherapy, radiotherapy, or immunotherapy for CLL
3) 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)
4) 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.
5) Pregnant or breast feeding females are not eligible.