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Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)


Phase 2
65 Years
N/A
Open (Enrolling)
Both
Advanced Cancers, Leukemia

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Trial Information

Phase II Study of Ofatumumab as Front-line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia (CLL)


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.


Inclusion Criteria:



1. Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of
signing informed consent.

2. ECOG/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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Alessandra Ferrajoli, MD,BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0520

NCT ID:

NCT01444716

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Advanced Cancers
  • Leukemia
  • Advanced Cancers
  • Leukemia
  • Chronic Lymphocytic Leukemia
  • CLL
  • Elderly
  • Ofatumumab
  • Arzerra
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030