Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn if it is possible to collect stem cells
      after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects,
      number of stem cells collected, and the number of procedures that are needed to collect
      enough stem cells.
    

Detailed description: 
      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 Days 2, 3, and 4, you will receive ifosfamide and mesna continuously and etoposide every
      12 hours. Mesna is given to help decrease the risk of developing side effects.

      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
      investigational.

      Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
    

Intervention name(s): Ofatumumab; Ifosfamide; Etoposide; Mesna; G-CSF; Stem Cell Collection
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8; 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.; 150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.; 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts)
2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide)
After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose.; 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.; Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.
Other intervention name(s): Arzera; Ifex; VePesid; Mesnex; Filgrastim; Neupogen; Granulocyte colony-stimulating factor; GCSF; Apheresis
Intervention MeSH terms: Etoposide; Ifosfamide; Ofatumumab; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy; Stem Cell Collection; Ofatumumab; Arzerra; Ifosfamide; Ifex; Etoposide; VePesid; Mesna; Mesnex; G-CSF; Filgrastim; Neupogen; Apheresis