Non-Hodgkin's LymphomaPhase 2NCT00076349
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing bendamustine and rituximab in people with Non-Hodgkin's Lymphoma, run by Cephalon at 34 sites in 3 countries.
Trial summary
SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- bendamustine and rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 34 sitesin 3 countries
- Study dates
- Apr 2004to Mar 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented B-Cell NHL or mantle cell lymphoma
- CD-20+ tumor
- Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
- Maximum of three prior chemotherapy regimens
- Age of at least 18 years at Screening Visit (Site specific requirement may differ)
Who cannot join
- Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
- Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
- Use of investigational agents within 28 days of study
- History of prior high dose chemotherapy with allogeneic stem cell support
- History of prior radioimmunotherapy
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States25 sites
Alaska Cancer Research and Education Center
Anchorage, Alaska, 99508
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Southwest Regional Cancer Center
Austin, Texas, 78705
Beth Israel/Deaconess Medical Center
Boston, Massachusetts, 02215
Univ. of Virginia Health System-Cancer Center Clinical Trials Office
Charlottesville, Virginia, 22908
John B. Amos Cancer Center
Columbus, Georgia, 31902
Bay Area Cancer Research Group
Concord, California, 94520
Baylor University Medical Center
Dallas, Texas, 75246
Arena Oncology Associates
Great Neck, New York, 11021
Wilshire Oncology Medical Group
La Verne, California, 91750
Suburban Hematology & Oncology Associates
Lawrenceville, Georgia, 30045
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute
Los Angeles, California, 90033
Georgia Oncology Partners Research and Education Foundation
Macon, Georgia, 31201
ACORN - West Cancer Center
Memphis, Tennessee, 38120
Oncology and Hematology
Metairie, Louisiana, 70006-2921
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Pasco Hernando Oncology
New Port Richey, Florida, 34652
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422
Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology
Rochester, New York, 14623
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center
Stamford, Connecticut, 06902-3628
San Diego Cancer Center
Vista, California, 92081
Georgetown University Medical Center - Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Canada5 sites
The Royal Victoria Hospital Cancer Care Program Clinical Trials
Barrie, Ontario, L4M 6M2
North Eastern Ontario Regional Cancer Center
Greater Sudbury, Ontario, P3E 5J1
Queen Elizabeth II Health Sciences Centre-Victoria General Site
Halifax, Nova Scotia, B3H 2Y9
Hopital Notre-Dame Du Chum
Montreal, Quebec, H2L 4MI
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Australia4 sites
St. Vincent's Hospital
Darlinghurst, NSW 2010
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Royal Melbourne Hospital
Parkville, Victoria, 3050
Westmead Hospital
Westmead, NSW 2145
About this study
Official title: A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
SUMMARY:
This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression.
Read more
RATIONALE:
Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients.
PURPOSE:
This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- bendamustine and rituximab
- Keywords
- Non-Hodgkin's Lymphoma, NHL, Rituxan, Mantle Cell, mabs
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustine and rituximabDrug
Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab Receives: Drug: bendamustine and rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma
Measured: 4-6 months
Secondary outcomes (1)
• To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR)
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2004 (estimated)
- Study startApr 2004
- Primary completionDec 2005
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076349
- Sponsor's protocol ID
- SDX-105-02
- Status last verified
- May 2014
- First submitted
- 20 Jan 2004
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT00076349
- Acronym / sponsor ID
- SDX-105-02
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, NHL, Rituxan, Mantle Cell, mabs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Jan 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.
SUMMARY:
This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression.
RATIONALE:
Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients.
PURPOSE:
This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bendamustine and rituximabopen-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented B-Cell NHL or mantle cell lymphoma
- CD-20+ tumor
- Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
- Maximum of three prior chemotherapy regimens
- Age of at least 18 years at Screening Visit (Site specific requirement may differ)
Key exclusion criteria (5 listed)
- Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
- Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
- Use of investigational agents within 28 days of study
- History of prior high dose chemotherapy with allogeneic stem cell support
- History of prior radioimmunotherapy
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 |
|---|---|---|
| bendamustine and rituximabPatients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered. | Drug | 1 |
Primary outcome
Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma
Time frame: 4-6 months
1 secondary outcome
• To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR)
Time frame: 4-6 months
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 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bendamustine and rituximab in people with Non-Hodgkin's Lymphoma, run by Cephalon at 34 sites in 3 countries.
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 5 inclusion and 5 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada, Australia. 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?
Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma (time frame: 4-6 months). 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 May 2014.