Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444716
Recruitment Status : Active, not recruiting
First Posted : October 3, 2011
Last Update Posted : January 11, 2018
National Comprehensive Cancer Network
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if ofatumumab can help to control CLL. The safety of this drug will also be studied.

Ofatumumab is designed to bind to the surface of the leukemia cells . This may cause the leukemia cells to die.

Condition or disease Intervention/treatment Phase
Advanced Cancers Leukemia Drug: Ofatumumab Phase 2

Detailed Description:

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive ofatumumab by vein every week for 4 weeks. After that, you will receive it every month. Each infusion will last about 4 hours.

Before you receive ofatumumab, you will be given drugs to help reduce the risk of side effects.

  • You will take Tylenol (acetaminophen) by mouth.
  • You will receive diphenhydramine by vein over about 5 minutes.
  • You will receive a steroid by vein over about 5 minutes.
  • You will take allopurinol by mouth during the first 14 days of treatment.

Study Visits:

Every other week, blood (about 1 teaspoon) will be drawn for routine tests.

Every month, you will have a physical exam. If your doctor thinks it is needed, you will also have a bone marrow biopsy to check the status of the disease.

After Month 6 and every 6 months after that, you will have a bone marrow biopsy and aspiration to check the status of the disease.

Length of Treatment:

You may continue receive the study drug for up to 12 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Ofatumumab is FDA approved for the treatment of chronic lymphocytic leukemia that has relapsed. Its use in this study for initial treatment of CLL is investigational.

Up to 34 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : December 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Ofatumumab
Four weekly intravenous infusions at 300 mg during week 1, then 2,000 mg weeks 2, 3 and 4, then monthly during months 2-12.
Drug: Ofatumumab
Starting dose: 300 mg by vein during week 1, then 2000 mg in weeks 2, 3 and 4, then monthly during months 2-12.
Other Name: Arzerra

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 6 months ]
    Number of participants with Overall Response (OR) which equals Complete and Partial Responses (CR+PR) divided by total number of participants. Response assessed after month 3, month 6 and every 6 months thereafter using the 2008 National Cancer Institute (NCI) Working Group criteria for response.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.
  2. The Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 2-3.or patients with chronic lymphocytic leukemia requiring treatment age >65 years at the time of signing informed consent and ECOG/WHO performance status of 0-1 and a CIRS or Charlson co-morbidity score of 2 or higher.
  3. Adequate renal and hepatic function (creatinine <2mg/dL and eGFR more than 30cc/minute, bilirubin <2mg/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.

Exclusion Criteria:

  1. Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
  2. Known positivity for HIV.
  3. Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HGsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
  4. Prior treatment for chronic lymphocytic leukemia.
  5. Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not compromising bone marrow function does not apply. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
  6. Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
  7. Any known hypersensitivity to ofatumumab or its components.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444716

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Comprehensive Cancer Network
Principal Investigator: Alessandra Ferrajoli, MD,BS M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01444716     History of Changes
Other Study ID Numbers: 2011-0520
15857 ( Other Identifier: GlaxoSmithKline )
NCCN-006 ( Other Identifier: National Comprehensive Cancer Network (NCCN) )
NCI-2013-00726 ( Registry Identifier: NCI CTRP )
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs