Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in… (NCT01329900) | Clinical Trial Compass
CompletedPhase 2
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
United States50 participantsStarted 2011-08-22
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients with histologically confirmed CD20 positive B-cell NHL who are candidates for autologous SCT.
✓. Patients must have PR to salvage chemotherapy.
✓. Age 18-70 years.
✓. Platelet count \>/= 100,00 mm³ independent of transfusion support.
✓. Absolute neutrophil count \>/= 1500/mm³.
✓. Zubrod performance status (PS) 2 or less.
✓. 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.
✓. Less than 5% marrow involvement with NHL within 4 weeks of study as defined by unilateral bone marrow aspiration and biopsy.
Exclusion criteria
✕. 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.)
✕. Active CNS disease.
✕. Severe concomitant medical or psychiatric illness.