Non-Hodgkin's LymphomaPhase 2NCT00225212
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab 375 mg/m2 in people with Non-Hodgkin's Lymphoma and Diffuse Large Cell Lymphoma, run by Stanford University at 1 site in United States.
Trial summary
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects. This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Rituximab 375 mg/m2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Mar 2003
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- B-cell, CD20+ NHL
- Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Creatinine < 2 mg/dL
- Bilirubin < 2.0 mg/dL
- Liver function tests (LFTs) < 5 x upper limit of normal (ULN)
Who cannot join
- Graft source from bone marrow
- Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20 therapy
- PD after ASCT
- Post-ASCT radiotherapy
- Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
- Evidence of active pneumonitis
Show all 10Show fewer
- Evidence of active infection
- Concurrent prednisone or other systemic steroid medication
- Nitrosourea therapy within 6 weeks of the first treatment with rituximab
- Presence of anti-murine antibody (HAMA) reactivity
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.
This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.
Read the detailed description
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.
After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.
- Conditions
- Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma, Transformed Lymphoma, Other Subtypes of B-cell Lymphoma, Lymphoma
- Being tested
- Rituximab 375 mg/m2
- Keywords
- non-Hodgkin's lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, transformed lymphoma, other subtypes of B cell lymphoma, recurrent lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab 375 mg/m2Drug
Also called Rituxan, MabThera, Zytux, IDEC-C2B8
| Study group | Role | What they receive |
|---|---|---|
| Rituximab after ASCT | Experimental | Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT. Receives: Drug: Rituximab 375 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
"Events" for EFS were defined as the earlier of post-ASCT relapse or death.
Measured: 24 months
Secondary outcomes (1)
Overall Survival (OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startNov 1997
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra J Horning, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225212
- Sponsor's protocol ID
- protocol97
- Other IDs
- 73750
- Status last verified
- Sep 2014
- First submitted
- 21 Sep 2005
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Horwitz SM, Negrin RS, Blume KG, Breslin S, Stuart MJ, Stockerl-Goldstein KE, Johnston LJ, Wong RM, Shizuru JA, Horning SJ. Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin lymphoma. Blood. 2004 Feb 1;103(3):777-83. doi: 10.1182/blood-2003-04-1257. Epub 2003 Aug 7.
PubMed 12907446
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00225212
- Acronym / sponsor ID
- protocol97
- Conditions
- Non-Hodgkin's Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma, Transformed Lymphoma, Other Subtypes of B-cell Lymphoma, Lymphoma
- Keywords
- non-Hodgkin's lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, transformed lymphoma, other subtypes of B cell lymphoma, recurrent lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 1997
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.
This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.
Detailed description
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.
After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab after ASCT | Experimental | Drug: Rituximab 375 mg/m2Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- B-cell, CD20+ NHL
- Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Creatinine < 2 mg/dL
- Bilirubin < 2.0 mg/dL
Key exclusion criteria (10 listed)
- Graft source from bone marrow
- Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20 therapy
- PD after ASCT
- Post-ASCT radiotherapy
- Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
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 |
|---|---|---|
| Rituximab 375 mg/m2Also: Rituxan, MabThera, Zytux, IDEC-C2B8 | Drug | Rituximab after ASCT |
Primary outcome
Event-free Survival (EFS)
Time frame: 24 months
"Events" for EFS were defined as the earlier of post-ASCT relapse or death.
1 secondary outcome
Overall Survival (OS)
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12907446Horwitz SM, Negrin RS, Blume KG, Breslin S, Stuart MJ, Stockerl-Goldstein KE, Johnston LJ, Wong RM, Shizuru JA, Horning SJ. Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin lymphoma. Blood. 2004 Feb 1;103(3):777-83. doi: 10.1182/blood-2003-04-1257. Epub 2003 Aug 7.
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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.
Sandra J Horning, MD principal investigator
Stanford University
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 375 mg/m2 in people with Non-Hodgkin's Lymphoma and Diffuse Large Cell Lymphoma, run by Stanford University 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 6 inclusion and 10 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 15 Sep 2014. 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?
Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Event-free Survival (EFS) (time frame: 24 months). 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 NCT00225212, 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 15 Sep 2014.