Clinical trial · Interventional
Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT01258933CI-TRIAL-00096081terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ofatumumab | Drug | Ofatumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ofatumumab
- description
- Ofatumumab 300 mg dose 1, then 1,000 mg weekly \* 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance.
- interventionNames
- Drug: Ofatumumab
Primary outcomes (1)
- measure
- Number of Patients With Objective Response
- timeFrame
- Week 12
- description
- Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of CD20+ chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with chemotherapy or chemoimmunotherapy: Post-frontline therapy, patients must have non-progressing disease and be 4 months to 1 year post treatment. Post-treatment for relapsed CLL, eligible patients must have non-progressing disease and be 3 months to 1 year post treatment. 2. Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may include MRD by 4-color flow cytometry. 3. Adequate renal and hepatic function (creatinine \< 2 mg/dL, bilirubin \< 2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. Patients with Gilbert's syndrome are eligible. 4. Age \>/= 18 years. 5. ECOG performance status of 0-2. 6. Provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the MDACC IRB. 7. Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study. Exclusion Criteria: 1. 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 subject will be excluded. 2. Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not comprising bone marrow function does not apply. 3. Active infection or significant medical illness, including current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver involved with CLL or stable chronic liver disease per investigator assessment). 4. Pregnant and breastfeeding females are excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.