Phase 2 N=84 Randomized Treatment

G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00499343 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcome: Primary: CD34+ Cells/kg in Blood Stem Cells — 7.5; 10.34 CD34+ cells/kg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Etoposide (Drug); G-CSF (Drug); GM-CSF (Drug); Isophosphamide (Drug); Rituximab (Drug); Apheresis (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY CD34+ Cells/kg in Blood Stem Cells	7.5; 10.34	—

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.

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

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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.