Phase 2
Completed N=20
Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
Source: ClinicalTrials.gov NCT01097057 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Jul 2017
Primary outcomePrimary: Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) — 17 Participants
Summary
This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) |
17 | — |
| PRIMARY Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days |
17 | — |
| PRIMARY Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg |
15; 2; 0; 0 | — |
| PRIMARY Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CD20+ non-Hodgkin's lymphoma
- Left ventricular ejection fraction at rest >= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
- Bilirubin = 50 mL/min
- Signed informed consent
- Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)
Exclusion Criteria
- Karnofsky performance score 5 years previously will be allowed
- Pregnant or breastfeeding
- Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
- Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
- Human immunodeficiency virus (HIV) positive
- Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
- Hepatitis B carriers
Data sourced from ClinicalTrials.gov (NCT01097057). 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.