Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01243190
First received: November 12, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 2016 (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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243190

Contacts
Contact: William G. Wierda, MD, PhD, BS 713-745-0428

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
GlaxoSmithKline
Investigators
Study Chair: William G. Weirda, MD, PhD, BS UT MD 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: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
leukemia
small lymphocytic leukemia
SLL
CLL
ofatumumab
untreated
early stage
high-risk

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

ClinicalTrials.gov processed this record on July 10, 2014