Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: November 12, 2010
Last updated: September 21, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ofatumumab Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients With Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Complete Response (CR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Response assessment 3 months after last dose of Ofatumumab. 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.

Estimated Enrollment: 44
Study Start Date: March 2011
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab
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
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).
Other Name: Arzerra

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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 </= 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.

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 </= 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01243190

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: William G. Weirda, MD, PhD, BS M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01243190     History of Changes
Other Study ID Numbers: 2010-0241  NCI-2011-00745 
Study First Received: November 12, 2010
Last Updated: September 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
small lymphocytic leukemia
early stage

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 09, 2016