Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
The Study Drugs:
Ofatumumab is a human monoclonal antibody for the CD20 protein designed to bind to the
surface of some of the white blood cells (B-cells). It can destroy cancer cells that come
from B-cells, and can be used to treat cancers of B-cells such as resistant CLL (chronic
Etoposide is designed to slow or stop the growth of cancer cells.
Filgrastim promotes the growth of white blood cells, which help to fight infections.
Ifosfamide is designed to slow or stop the growth of cancer cells.
Mesna is a drug that protects bladder cells from damage by the chemotherapy drug ifosfamide.
It is used to decrease the risk of bleeding in the bladder.
You will be admitted to the hospital. You will have to stay in the hospital for 4-6 days for
this part of the treatment.
On Day 1, you will receive ofatumumab through the CVL over 6-8 hours.
On Day 2-5, you will begin receiving ifosfamide as a non-stop infusion for a total of 72
hours. Beginning on Day 2, you will also receive etoposide over 2 hours every 12 hours for
a total of 6 doses.
To help decrease the risk of developing side effects, you will be given fluids by CVL and a
drug called mesna. Mesna will be given by CVL before starting ifosfamide and continue for
12 hours after treatment with ifosfamide is finished.
As an outpatient, you will receive a higher dose of ofatumumab (about 1 week after the first
one) through the CVL over 10-12 hours.
Beginning on Day 6, you will get G-CSF (filgrastim) injections (given under the skin) and
will continue to be given until enough stem cells have been collected.
Tests and Procedures:
Every day while you are in the hospital, you will have a physical exam and you will be asked
about any side effects you may be having. After you are no longer in the hospital, you will
have a physical exam and you will be asked about any side effects you may be having when the
doctor thinks it is needed.
While you are waiting for enough stem cells to be collected, you will have blood drawn
(about 1 tablespoon) for routine tests at least 3 times a week. If your doctor thinks it is
needed, you may have blood drawn more often.
Stem Cell Collection:
Blood stem cells will be collected when your blood counts have returned to normal (about
10-16 days after chemotherapy). The process of stem cell collection takes about 4 hours each
time. You will have stem cells collected each day until enough are collected (between 1-6
sessions). A machine is attached to the CVL and blood is withdrawn. The blood then flows
through the machine, which removes stem cells from the blood. The blood is then returned
back to you through the CVL. The stem cells are then frozen and stored. These stem cells
will be given back to you after the next phase of treatment to help your blood counts
recover after high dose chemotherapy. After enough stem cells have been collected, you will
be admitted to the hospital for high dose chemotherapy. You will sign a separate consent
before you receive high dose chemotherapy.
During the stem cell collection, blood (about 2 teaspoons) will be drawn through the CVL to
check for cell markers that can affect the response of the cell counts and to check the
status of the disease.
Length of Study:
Patients will be followed for up to 12 months after the transplant. You will be taken off
study early if the stem cell collection does not work.
This is an investigational study. Etoposide and ifosfamide are FDA approved and are
commercially available for lymphomas. Ofatumumab has been approved by the FDA for treatment
of recurrent refractory chronic lymphocytic leukemias. G-CSF and Mesna are FDA approved and
commercially available. The use of Ofatumumab for the collection of stem cells is
Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of Mobilization with Ofatumumab Plus Chemotherapy
Physical examination and toxicity evaluation at least weekly while the patient is hospitalized and as clinically indicated for outpatients.
Weekly (up to 12 months)
Issa F. Khouri, MD,BS
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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