Clinical trial · Interventional
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
NCT01329900CI-TRIAL-00045858completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Ofatumumab | Drug | Ofatumumab | ALIAS |
| Stem Cell Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ofatumumab + Stem Cell Collection
- description
- Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 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. G-CSF 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.
- interventionNames
- Drug: Ofatumumab
- Drug: Ifosfamide
- Drug: Etoposide
- Drug: Mesna
- Drug: G-CSF
- Procedure: Stem Cell Collection
Primary outcomes (1)
- measure
- Mobilization Rate
- timeFrame
- Mobilization rate measured on Day 21
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.