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Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)


The Study Drug:

Ofatumumab is designed to bind to the surface of some white blood cells (B-cells) and to
kill these cells. It can destroy cancer cells that come from B-cells, and can be used to
treat cancers of B-cells such as B-CLL.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive ofatumumab up
to 20 times during this study. You will receive 8 weekly infusions and then an infusion
every 2 months for 2 years or until the disease gets worse. You will receive ofatumumab by
vein over about 6 ½ hours the first time and over 4 hours for all the following infusions.
The first infusion will be the smallest dose. The second and later infusions will be 3 times
larger than the first.

Before you receive the study drug each time, you will receive Tylenol (acetaminophen) by
mouth to reduce the risk of fever. You will receive Benadryl (diphenhydramine) by mouth or
vein and prednisolone (a steroid) by vein over about 30 minutes to reduce the risk of an
allergic reaction or an infusion reaction.

During the infusions, you will be monitored closely. You will be expected to stay in clinic
for about 71/2 hours on the day of the first infusion and 5 hours for all other infusions.

You will be seen at MD Anderson for mandatory visits for enrollment, ofatumumab infusions,
for response assessment after 8 weekly ofatumumab doses (Month 3), during maintenance every
6 months and for follow-up at least once a year. Your local doctor may perform other visits
and laboratory studies.

If you decide to have your local doctor perform study visits and laboratory studies, a
letter will be sent to your doctor, describing your participation in this study and asking
for your doctor's agreement to help manage your care.

Study Visits:

The following tests and procedures will be performed every other week during Weeks 1- 8
(Weeks 1, 3, 5 and 7):

- You will have a complete physical exam including measurement of your vital signs.

- Your medical history will be recorded.

- Blood (about 2 teaspoons) will be drawn for routine tests.

Starting at Month 3, you will have the following tests and procedures every 2 Months:

- You will have a complete physical exam including measurement of your vital signs.

- Your medical history will be recorded.

- Blood (about 2 teaspoons) will be drawn for routine tests.

Starting at Month 3, you will also have the following tests and procedures every 6 months,
in addition to the ones performed every 2 months:

- Blood (about an additional 1 teaspoon) will be drawn for other routine tests.

- You may have CT scans to check the status of the disease, if your doctor thinks that
this test is needed (at Month 3 only).

- You will have a bone marrow aspirate/biopsy to check the status of the disease.

Length of Study:

You may continue taking the study drug for up to 20 doses (up to 24 months). You will no
longer be able to take the study drug if the disease gets worse or intolerable side effects
occur.

Your participation on the study will be over once you have completed the follow-up visits,
which will last until you begin receiving any other treatment.

Follow Up Visits:

Every 3 Months:

- You will have a complete physical exam including measurement of your vital signs.

- Your medical history will be recorded.

- Blood (about 2 teaspoons every 3 months, about 1 teaspoon every 6 months) will be drawn
for routine tests.

- If your doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for
hepatitis testing.

Every 6 Months, you will have a bone marrow aspirate/biopsy to check the status of the
disease.

This is an investigational study. Ofatumumab is FDA approved for CLL resistant to standard
chemotherapy. Ofatumumab's use in patients with residual CLL or SLL is investigational.

Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Diagnosis of CD20+ chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL) treated with chemotherapy or chemoimmunotherapy: Post-frontline therapy,
patients must have non-progressing disease and be 4 months to 1 year post treatment.
Post-treatment for relapsed CLL, eligible patients must have non-progressing disease
and be 3 months to 1 year post treatment.

2. Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may
include MRD by 4-color flow cytometry.

3. Adequate renal and hepatic function (creatinine < 2 mg/dL, bilirubin < 2 mg/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.

4. Age >/= 18 years.

5. ECOG performance status of 0-2.

6. Provide informed consent indicating patient is aware of the investigational nature of
this study according to the policies of the MDACC IRB.

7. Patients of childbearing potential (females who have not been postmenopausal for at
least 12 consecutive months or who have not undergone previous surgical sterilization
or males who have not been surgically sterilized) must be willing to practice birth
control during the study.

Exclusion Criteria:

1. 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 subject will be excluded.

2. Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal
antibodies. Localized radiotherapy to an area not comprising bone marrow function
does not apply.

3. Active infection or significant medical illness, including current active hepatic or
biliary disease (with exception of patients with asymptomatic gallstones, liver
involved with CLL or stable chronic liver disease per investigator assessment).

4. Pregnant and breastfeeding females are excluded.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients with Objective Response

Outcome Description:

Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.

Outcome Time Frame:

Week 12

Safety Issue:

No

Principal Investigator

William G Wierda, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0266

NCT ID:

NCT01258933

Start Date:

July 2011

Completion Date:

July 2015

Related Keywords:

  • Leukemia
  • Lymphoma
  • Leukemia
  • Chronic Lymphocytic Leukemia
  • CLL
  • Lymphoma
  • Small Lymphocytic Lymphoma
  • SLL
  • Ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Neoplasm, Residual

Name

Location

U.T. M.D. Anderson Cancer CenterHouston, Texas  77030