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
Intervention: Ofatumumab; Ifosfamide; Etoposide; Mesna; G-CSF; Stem Cell Collection
Intervention description: 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.
Intervention MeSH terms: Etoposide; Ifosfamide; Ofatumumab; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chemotherapy; Stem Cell Collection; Ofatumumab; Arzerra; Ifosfamide; Ifex; Etoposide; VePesid; Mesna; Mesnex; G-CSF; Filgrastim; Neupogen; Apheresis

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.
    

Eligibility criteria:

        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.
             (Consult with a physician experienced in care and management of subjects with
             hepatitis B to manage/treat subjects who are anti-HBc positive.)

          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.