G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
1 other identifier
interventional
84
1 country
1
Brief 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.
- 3.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.
- 4.To determine the incidence of disease progression/relapse at 12 months in the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Jan 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 9, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 7, 2009
CompletedAugust 2, 2013
June 1, 2013
4.8 years
July 9, 2007
March 3, 2009
June 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CD34+ Cells/kg in Blood Stem Cells
After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.
The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.
Study Arms (2)
Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
EXPERIMENTALGrowth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
EXPERIMENTALGrowth Factor = granulocyte-colony stimulating factor (G-CSF)
Interventions
150 mg/m\^2 given intravenously over 2 hours every 12 hours x 6 doses.
Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
250 mcg/m\^2 injection given every evening till the completion of apheresis.
10 g/m\^2 given intravenously continuous infusion over 72 hours.
Days +1 (375 mg/m\^2) and +8 (1000 mg/m\^2) given intravenously.
Peripheral blood stem cell collection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Bayercollaborator
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hosing C, Munsell MF, Reuben JM, Popat U, Lee BN, Gao H, Korbling M, Shpall EJ, Kebriaei P, Alousi A, De Lima M, McMannis J, Qazilbash M, Anderlini P, Giralt S, Champlin RE, Khouri I. A randomized study comparing chemotherapy followed by G-CSF alone or in combination with GM-CSF for mobilization of peripheral blood stem cells in patients with non-Hodgkin's lymphomas. J Blood Med. 2010;1:49-55. doi: 10.2147/JBM.S9846. Epub 2010 Apr 14.
PMID: 22282683DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chitra M. Hosing, MD / Associate Professor
- Organization
- U.T. M.D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Chitra M. Hosing, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2007
First Posted
July 11, 2007
Study Start
January 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
August 2, 2013
Results First Posted
July 7, 2009
Record last verified: 2013-06