Overview

Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Status:
Active, not recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
GlaxoSmithKline
Treatments:
Antibodies, Monoclonal
Ofatumumab
Criteria
Inclusion Criteria:

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
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.

Exclusion Criteria:

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 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.