Phase 2
Completed N=84
G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
Source: ClinicalTrials.gov NCT00499343 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcomePrimary: CD34+ Cells/kg in Blood Stem Cells — 7.5; 10.34 CD34+ cells/kg
Summary
Primary Objectives:
1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups.
Secondary Objectives:
1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging.
2. To determine the incidence of disease progression/relapse at 12 months in the two groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD34+ Cells/kg in Blood Stem Cells |
7.5; 10.34 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation.
- Age up to 70 years
- Platelet count > 100, 000 mm3, independent of transfusion support
- Absolute neutrophil count (ANC) > 1500/mm3
- Zubrod performance status of 2 or less.
- Negative pregnancy test in women
- Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as defined by bilateral bone marrow aspirations and biopsies.
- Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C antibody.
Exclusion Criteria
- Clinical or radiographic evidence of active CNS disease
- Severe concomitant medical or psychiatric illness
- Lactating or breast feeding females
- Less than 3 weeks from the first day of last chemotherapy
- Prior myeloablative therapy with autologous bone marrow or stem cell rescue
- Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.
- Serum creatinine >1.6 mg/dl
- History of pelvic radiation
- Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation)
- Patients should not have received more than 6 cycles of fludarabine therapy
Data sourced from ClinicalTrials.gov (NCT00499343). 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.