Phase 2
Completed N=50
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
Source: ClinicalTrials.gov NCT01329900 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Jul 2020
Primary outcomePrimary: Mobilization Rate — 50 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mobilization Rate |
50 | — |
Eligibility Criteria
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.
- Seronegativity for HIV, HTLV1, Hepatitis .
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.
- Lactating or breast feeding females.
- Serum creatinine >1.6 mg/dl.
- History of pelvic radiation.
- Fludarabine-based chemotherapy within 6 months.
Data sourced from ClinicalTrials.gov (NCT01329900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.