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Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

Phase 2
18 Years
70 Years
Open (Enrolling)

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Trial Information

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
lymphocytic leukemia).

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.

Treatment Administration:

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.

Inclusion Criteria:

1. Patients with histologically confirmed CD20 positive B-cell NHL who are candidates
for autologous SCT.

2. Patients must have PR to salvage chemotherapy.

3. Age 18-70 years.

4. Platelet count >/= 100,00 mm³ independent of transfusion support.

5. Absolute neutrophil count >/= 1500/mm³.

6. Zubrod performance status (PS) 2 or less.

7. Negative serum pregnancy test in women of childbearing potential. This is a female
who has not been postmenopausal for at least 12 consecutive months or who has not
undergone previous surgical sterilization.

8. Less than 5% marrow involvement with NHL within 4 weeks of study as defined by
unilateral bone marrow aspiration and biopsy.

9. Seronegativity for HIV, HTLV1, Hepatitis .

Exclusion Criteria:

1. Subjects who have current active hepatic ( (HbsAg, HbcAb, and positive viral load by
PCR) or biliary disease (with exception of patients with Gilbert's syndrome,
asymptomatic gallstones, liver metastases or stable chronic liver disease per
investigator assessment) with ALT > 2x upper limit of normal or bilirubin > 1.5.

2. Active CNS disease.

3. Severe concomitant medical or psychiatric illness.

4. Lactating or breast feeding females.

5. Serum creatinine >1.6 mg/dl.

6. History of pelvic radiation.

7. Fludarabine-based chemotherapy within 6 months.

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility of Mobilization with Ofatumumab Plus Chemotherapy

Outcome Description:

Physical examination and toxicity evaluation at least weekly while the patient is hospitalized and as clinically indicated for outpatients.

Outcome Time Frame:

Weekly (up to 12 months)

Safety Issue:


Principal Investigator

Issa F. Khouri, MD,BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

Related Keywords:

  • Lymphoma
  • Chemotherapy
  • Stem Cell Collection
  • Ofatumumab
  • Arzerra
  • Ifosfamide
  • Ifex
  • Etoposide
  • VePesid
  • Mesna
  • Mesnex
  • G-CSF
  • Filgrastim
  • Neupogen
  • Apheresis
  • Lymphoma
  • Lymphoma, Non-Hodgkin



UT MD Anderson Cancer CenterHouston, Texas  77030