LymphomaPhase 3NCT00052923
Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive B-Cell Diffuse Large Cell Lymphoma
A Phase 3 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by Eastern Cooperative Oncology Group.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, rituximab and carmustine
- Type of treatment
- Surgery or procedure
- How many people
- 427 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jun 2006
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of diffuse large cell lymphoma and meeting the following criteria:
- B-cell type with expression of CD20 either at diagnosis or at relapse
- Relapse after having achieved an initial complete remission (CR) or failure to achieve initial CR (residual radiographic abnormalities after primary therapy allowed if these abnormalities are also positive by positron emission tomography or MRI [gallium])
- No newly diagnosed disease
- No progressive or stable disease to most recent salvage therapy
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST or ALT < 3 times upper limit of normal
Renal
- Creatinine ≤ 2.0 mg/dL OR
- Creatinine clearance ≥ 40 mL/min
Cardiovascular
- Cardiac ejection fraction ≥ 40%
Pulmonary
- DLCO ≥ 60% of predicted
Other
- No other malignancy within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix
- No active infection requiring oral or IV antibiotics
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- No more than 3 prior immunotherapy regimens
Chemotherapy
- No more than 3 prior chemotherapy regimens
- Addition of radiation or a monoclonal antibody to chemotherapy is considered one treatment regimen if the addition was part of the initial treatment plan
- Addition of these therapies due to lack of response or poor response would be considered an additional treatment regimen whether given in front-line or salvage setting
Endocrine therapy
- Not specified
Radiotherapy
- See Chemotherapy
- No more than 3 prior radiotherapy regimens
- No prior radioimmunotherapy
Surgery
- Not specified
About this study
Official title: Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.
Read the detailed description
OBJECTIVES:
- Compare disease-free survival of patients with relapsed or progressive B-cell diffuse large cell lymphoma undergoing stem cell transplantation with or without post-transplant rituximab.
- Evaluate the effect of rituximab, administered post-transplant, on the procedure-related mortality of these patients.
- Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with positive positron emission tomography or MRI [gallium] vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI [gallium]) and prior rituximab (yes vs no).
Stem cell mobilization
- Patients receive rituximab IV over 4-8 hours on days 1 and 5. Patients also receive cyclophosphamide IV over 2 hours on day 8 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until the last day of apheresis. Stem cells are collected over 1-3 days.
Preparative regimen
- Regimen A (patients who have received prior radiotherapy or are ≥ 61 years of age): Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.
- Regimen B (all other patients): Patients undergo total body irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2.
Stem cells are reinfused on day 0. Patients are then randomized to one of two post-transplant treatment arms.
Post-transplant treatment
- Arm I (rituximab): Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients receive rituximab IV over 4-8 hours every 7 days for 4 doses, starting on day 45 post-transplant. Course of rituximab is repeated beginning on day 180 post-transplant.
- Arm II (no rituximab): Patients receive G-CSF as in arm I. Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 427 patients will be accrued for this study within 3.5 years.
- Conditions
- Lymphoma
- Being tested
- filgrastim, rituximab, carmustine, cyclophosphamide, etoposide
- Keywords
- recurrent adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
rituximabBiological
carmustineDrug
cyclophosphamideDrug
etoposideDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (3)
Procedure-related mortality
Overall survival
Potential infectious complications of the addition of rituximab to autologous stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2003
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 427 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B
- Investigators
- Ian W. Flinn, MD, PhD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsCharles A. Linker, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052923
- Sponsor's protocol ID
- CDR0000258802
- Other IDs
- ECOG-E2499, CALGB-50205, CALGB-E2499
- Status last verified
- Jun 2006
- First submitted
- 24 Jan 2003
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00052923
- Acronym / sponsor ID
- CDR0000258802
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), Cancer and Leukemia Group B
- Study start
- Mar 2003
- Primary completion
- Jun 2006 (actual)
- First posted
- 27 Jan 2003 (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 work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.
Detailed description
OBJECTIVES:
- Compare disease-free survival of patients with relapsed or progressive B-cell diffuse large cell lymphoma undergoing stem cell transplantation with or without post-transplant rituximab.
- Evaluate the effect of rituximab, administered post-transplant, on the procedure-related mortality of these patients.
- Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with positive positron emission tomography or MRI [gallium] vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI [gallium]) and prior rituximab (yes vs no).
Stem cell mobilization
- Patients receive rituximab IV over 4-8 hours on days 1 and 5. Patients also receive cyclophosphamide IV over 2 hours on day 8 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until the last day of apheresis. Stem cells are collected over 1-3 days.
Preparative regimen
- Regimen A (patients who have received prior radiotherapy or are ≥ 61 years of age): Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.
- Regimen B (all other patients): Patients undergo total body irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2.
Stem cells are reinfused on day 0. Patients are then randomized to one of two post-transplant treatment arms.
Post-transplant treatment
- Arm I (rituximab): Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients receive rituximab IV over 4-8 hours every 7 days for 4 doses, starting on day 45 post-transplant. Course of rituximab is repeated beginning on day 180 post-transplant.
- Arm II (no rituximab): Patients receive G-CSF as in arm I. Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 427 patients will be accrued for this study within 3.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| filgrastim | Biological | – |
| rituximab | Biological | – |
| carmustine | Drug | – |
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Progression-free survival
3 secondary outcomes
Procedure-related mortality
Overall survival
Potential infectious complications of the addition of rituximab to autologous stem cell transplantation
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 9 Feb 2009.
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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.
Ian W. Flinn, MD, PhD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Charles A. Linker, MD study chair
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim, rituximab and carmustine in people with Lymphoma, run by Eastern Cooperative Oncology Group.
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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2009.