LymphomaPhase 2NCT00080886
Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma
A Phase 2 study testing rituximab, carmustine and cytarabine in people with Lymphoma, run by University of Nebraska at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so… Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, carmustine and cytarabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2002to 12 Mar 2015
- Phase
- Phase 2
- 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 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-Hodgkin's lymphoma
- o Any B cell
- CD20-positive disease
- Failed prior primary induction therapy
- Meets 1 of the following criteria:
- Chemotherapy-refractory disease
Show all 17Show fewer
- Received at least 3 prior chemotherapy regimens
- Mantle cell lymphoma
- Eligible for transplantation
- 19 years old and over
- WHO 0-2
- Life expectancy at least 6 months
- Absolute neutrophil count ≥ 1,000/mm^3*
- Platelet count > 50,000/mm^3*
- Hemoglobin > 9.0 g/dL*
- o NOTE: Unless due to lymphomatous involvement of the bone marrow
- Fertile patients must use 2 methods of effective contraception
Who cannot join
- No history of T-cell lymphoma
- Not pregnant or nursing
- No other concurrent serious disease or condition that would preclude study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Eppley Cancer Center
Omaha, Nebraska, 68198-7680
About this study
Official title: A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma.
- Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest.
Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0.
Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.
Patients are followed at day 100, at 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- rituximab, carmustine, cytarabine, etoposide, melphalan
- Keywords
- recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Also called Rituxan
carmustineDrug
Also called Gliadel Wafer, Bicnu
cytarabineDrug
Also called cytosine arabinoside
etoposideDrug
Also called Etopophos, Toposar
melphalanDrug
Also called Evomela
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Participants receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest.
Participants then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Participants undergo autologous hematopoietic stem cell transplantation on day 0. Participants who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks. Participants are followed at day 100, at 1 year, and then annually thereafter. Receives: Biological: rituximab; Drug: carmustine; Drug: cytarabine; Drug: etoposide; Drug: melphalan; Procedure: autologous bone marrow transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes.
To evaluate levels of soluble CD20 antigen (sCD20) in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous hematopoietic stem cell transplantation (AHSCT), and to examine the effect of changes in levels of sCD20 with clinical outcomes.
Measured: pre and post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study start8 May 2002
- Primary completion1 Nov 2005
- Study completion12 Mar 2015
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.
- More trials run by University of NebraskaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert G Bociek, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080886
- Sponsor's protocol ID
- 0063-02-FB
- Other IDs
- CDR0000357306
- Status last verified
- Oct 2023
- First submitted
- 7 Apr 2004
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00080886
- Acronym / sponsor ID
- 0063-02-FB
- Conditions
- Lymphoma
- Keywords
- recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2002 (actual)
- Primary completion
- 1 Nov 2005 (actual)
- Study completion
- 12 Mar 2015 (actual)
- First posted
- 8 Apr 2004 (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: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma.
- Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen.
- Determine the response rate in patients treated with this regimen.
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest.
Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0.
Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.
Patients are followed at day 100, at 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Biological: rituximab, Drug: carmustine, Drug: cytarabine, Drug: etoposide, Drug: melphalan, Procedure: autologous bone marrow transplantation, Procedure: peripheral blood stem cell transplantationParticipants receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest. Participants then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Participants undergo autologous hematopoietic stem cell transplantation on day 0. Participants who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks. Participants are followed at day 100, at 1 year, and then annually thereafter. |
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of non-Hodgkin's lymphoma
- o Any B cell
- CD20-positive disease
- Failed prior primary induction therapy
- Meets 1 of the following criteria:
Key exclusion criteria (3 listed)
- No history of T-cell lymphoma
- Not pregnant or nursing
- No other concurrent serious disease or condition that would preclude study participation
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 |
|---|---|---|
| rituximabAlso: Rituxan | Biological | Arm 1 |
| carmustineAlso: Gliadel Wafer, Bicnu | Drug | Arm 1 |
| cytarabineAlso: cytosine arabinoside | Drug | Arm 1 |
| etoposideAlso: Etopophos, Toposar | Drug | Arm 1 |
| melphalanAlso: Evomela | Drug | Arm 1 |
| autologous bone marrow transplantation | Procedure or surgery | Arm 1 |
| peripheral blood stem cell transplantation | Procedure or surgery | Arm 1 |
Primary outcome
evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes.
Time frame: pre and post transplant
To evaluate levels of soluble CD20 antigen (sCD20) in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous hematopoietic stem cell transplantation (AHSCT), and to examine the effect of changes in levels of sCD20 with clinical outcomes.
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 6 Oct 2023.
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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.
Robert G Bociek, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, carmustine and cytarabine in people with Lymphoma, run by University of Nebraska 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?
The sponsor lists 17 inclusion and 3 exclusion criteria. 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 6 Oct 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes. (time frame: pre and post transplant). 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 6 Oct 2023.