LymphomaNCT00274794
VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL
A study testing filgrastim and rituximab in people with Lymphoma, run by The Cleveland Clinic at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria:
- Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL)
- Patients with B-cell NHL in first remission and who have significant risk for later relapse
- Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation
PATIENT CHARACTERISTICS:
- Life expectancy at least 2 months
- Cardiac ejection fraction ≥ 45%
- DLCO ≥ 45%
- Creatinine < 2.0 mg/dL
- Bilirubin < 2.0 mg/dL
- AST < 2 times normal
- Platelet count ≥ 50,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Absolute lymphocyte count ≤ 10,000/mm^3
- HIV negative
- No severe medical or psychiatric illnesses
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- More than 8 weeks since prior rituximab
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
About this study
Official title: A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies
RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin's lymphoma.
- Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients.
OUTLINE: This is a randomized study.
- Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms.
- Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 17 and continuing until approximately day 25. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
- Arm II: Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
- Preparative regimen: Patients receive oral busulfan once daily on days -8 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on days -3 and -2.
- Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo autologous PBSCT on day 0. Beginning on day 5, patients receive G-CSF SC or IV once daily until blood counts recover.
After completion study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- filgrastim, rituximab
- Keywords
- noncontiguous stage II adult Burkitt lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage III adult immunoblastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide
rituximabBiological
375 mg/m2, IV, Once per week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rituxan + Etoposide + G-CSF | Other | Not described Receives: Biological: filgrastim; Biological: rituximab |
| Etoposide + G-CSF | Other | Not described Receives: Biological: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate CD34+ cell yields with the addition of rituximab
Measured: At least two weeks prior to transplant
Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF)
Measured: 100 days post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startFeb 2000
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Brian J. Bolwell, MD, Study chair, Cleveland Clinic Taussig Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274794
- Sponsor's protocol ID
- CASE-CCF-3600
- Other IDs
- P30CA043703, CASE-CCF-3600, CASE-CCF-0467
- Status last verified
- Mar 2011
- First submitted
- 10 Jan 2006
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Copelan E, Pohlman B, Rybicki L, Kalaycio M, Sobecks R, Andresen S, Dean R, Koo A, Chan J, Sweetenham J, Bolwell B. A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin's lymphoma. Bone Marrow Transplant. 2009 Jan;43(2):101-5. doi: 10.1038/bmt.2008.306. Epub 2008 Sep 15.
PubMed 18794865
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00274794
- Acronym / sponsor ID
- CASE-CCF-3600
- Conditions
- Lymphoma
- Keywords
- noncontiguous stage II adult Burkitt lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin's lymphoma.
- Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients.
OUTLINE: This is a randomized study.
- Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms.
- Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 17 and continuing until approximately day 25. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
- Arm II: Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
- Preparative regimen: Patients receive oral busulfan once daily on days -8 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on days -3 and -2.
- Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo autologous PBSCT on day 0. Beginning on day 5, patients receive G-CSF SC or IV once daily until blood counts recover.
After completion study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituxan + Etoposide + G-CSF | Other | Biological: filgrastim, Biological: rituximab |
| Etoposide + G-CSF | Other | Biological: filgrastim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide | Biological | Etoposide + G-CSF, Rituxan + Etoposide + G-CSF |
| rituximab375 mg/m2, IV, Once per week for 3 weeks. | Biological | Rituxan + Etoposide + G-CSF |
Primary outcome
Correlate CD34+ cell yields with the addition of rituximab
Time frame: At least two weeks prior to transplant
Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF)
Time frame: 100 days post transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
- Results publication: PubMed 18794865Copelan E, Pohlman B, Rybicki L, Kalaycio M, Sobecks R, Andresen S, Dean R, Koo A, Chan J, Sweetenham J, Bolwell B. A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin's lymphoma. Bone Marrow Transplant. 2009 Jan;43(2):101-5. doi: 10.1038/bmt.2008.306. Epub 2008 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J. Bolwell, MD study chair
Cleveland Clinic Taussig Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filgrastim and rituximab in people with Lymphoma, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate CD34+ cell yields with the addition of rituximab (time frame: At least two weeks prior to transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00274794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.