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

NCT01243190 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2010-0241NCI-2011-00745
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

leukemia; small lymphocytic leukemia; SLL; CLL; ofatumumab; untreated; early stage; high-risk

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Complete Response (CR)

  2008 International Workshop on CLL (IWCLL) update of the National Cancer Institute-sponsored Working Group (NCI-WG) outlined specific criteria of Complete Response (CR) for diagnosing CLL. CR is defined as Marrow normocellular, no CLL cells, no B-lymphoid nodules, hemoglobin of ≥11.0 g/dL (untransfused and without erythropoietin), Platelet count of ≥100 × 10\^9/L, circulating lymphocyte count normal, no constitutional symptoms, Liver and/or spleen size \<13 cm; liver size normal, lymph nodes ≥ 1.5 cm.

  Up to 12 years

Study Arms (1)

Ofatumumab

EXPERIMENTAL

Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).

Also known as: Arzerra

Ofatumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: William Wierda MD./Professor
• Organization: The university of Texas MD Anderson Cancer Center

wwierda@mdanderson.org

713-745-0428

Study Officials

• William G. Weirda, BS,MD,PhD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 18, 2010
• Study Start: March 1, 2011
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (1)