66 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants With a ResponsePrimary· Up to 3 years, 10 months
Response = (complete response \[CR\] + partial response \[PR\]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood.
Group
Value
95% CI
Treatment (Ofatumumab)
23
Progression-free Survival (PFS)Secondary· Up to 3 years, 10 months
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Group
Value
95% CI
Treatment (Ofatumumab)
21
9 – 32
Participants With a Complete Response (CR)Secondary· Up to 3 years, 10 months
Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.
Group
Value
95% CI
Treatment (Ofatumumab)
6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3 years, 10 Months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Ofatumumab)
Serious: 9/34 (26%)
Deaths: 0/34
Serious adverse events (15 terms)
Reaction
System
Treatment (Ofatumumab)
Diarrhea
Gastrointestinal disorders
—
Abdominal Pain
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Papillary Urothelial Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Transient Ichemic Attack
Nervous system disorders
—
Headache
Nervous system disorders
—
Hematuria
Renal and urinary disorders
—
Hip Fracture
Injury, poisoning and procedural complications
—
Myocardial Infarction
Cardiac disorders
—
Epistaxis
Respiratory, thoracic and mediastinal disorders
—
Aortic Valve Disease
Cardiac disorders
—
Fever
General disorders
—
Lung Infection
Infections and infestations
—
Thromboembolic Event
Vascular disorders
—
Other adverse events (29 terms — click to expand)
Reaction
System
Treatment (Ofatumumab)
Infusion Related Reaction
General disorders
—
Abdoninal Pain
General disorders
—
Pain
General disorders
—
Upper Respiratory Infection
Infections and infestations
—
Fever
General disorders
—
Infections
Infections and infestations
—
Urinary Tract Infection
Infections and infestations
—
Diarrhea
Gastrointestinal disorders
—
Fatigue
General disorders
—
Bone Fracture
Injury, poisoning and procedural complications
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
Hyperuricemia
Metabolism and nutrition disorders
—
Nausea
Gastrointestinal disorders
—
Other Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06486779 — Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
· recruiting
NCT06867991 — Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
· Phase 3
· recruiting
NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients
· active not recruiting
NCT07353216 — Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Se
· recruiting
NCT05809986 — Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
· recruiting
Other recruiting trials for Chronic Lymphocytic Leukemia
Currently open trials in the same condition.
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· Phase 1
· recruiting
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
· Phase 2
· recruiting
NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal
· Phase 2
· recruiting
NCT07288515 — Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
· recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
· Phase 2
· recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 26 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01444716.