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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
National Comprehensive Cancer Network
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01444716
First received: September 28, 2011
Last updated: June 13, 2014
Last verified: June 2014

September 28, 2011
June 13, 2014
December 2011
February 2016   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01444716 on ClinicalTrials.gov Archive Site
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Not Provided
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Phase II Study of Ofatumumab in Elderly Patients With Chronic Lymphocytic Leukemia (CLL)
Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Cancers
  • Leukemia
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
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.
Intervention: Drug: Ofatumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
Not Provided
February 2016   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact: Alessandra Ferrajoli, MD, BS 713-792-2063
United States
 
NCT01444716
2011-0520, 15857, NCCN-006, NCI-2013-00726
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • National Comprehensive Cancer Network
  • GlaxoSmithKline
Principal Investigator: Alessandra Ferrajoli, MD,BS UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP