Non-Hodgkin's LymphomaPhase 3NCT00139841
Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
A Phase 3 study testing Bendamustine HCl in people with Non-Hodgkin's Lymphoma, run by Cephalon at 40 sites in 3 countries.
Trial summary
SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). 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 HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 40 sitesin 3 countries
- Study dates
- Oct 2005to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented B-cell Non-Hodgkin's Lymphoma
- Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)
- Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
- Lymphoplasmacytic lymphoma
- Follicular center lymphoma, follicular
- Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination)
- At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens
- Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension
Who cannot join
- Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible
- History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States32 sites
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Arlington Cancer Center
Arlington, Texas, 76012
University of Colorado Cancer Center
Aurora, Colorado, 80010
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Tower Hematology and Oncology Medical Group
Beverly Hills, California, 90211
University of Alabama Birmingham
Birmingham, Alabama, 35233
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
Duke University School of Medicine
Durham, North Carolina, 27710
Indiana Oncology Hematology Consultants, A Division of AHN
Indianapolis, Indiana, 46202
Moores UCSD Cancer Center
La Jolla, California, 92093
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Markey Cancer Center, University of Kentucky Medical Center
Lexington, Kentucky, 40536
USC/Norris Cancer Hospital
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53792
The West Clinic/ACORN
Memphis, Tennessee, 38138
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 06520
Weill Cornell Cancer Care Center
New York, New York, 10021
Comprehensive Cancer Center - Desert Regional Medical Center
Palm Springs, California, 92662
Interlakes Foundation, Inc.
Rochester, New York, 14623
University of Rochester Medical Center, James P. Wilmot Cancer Center
Rochester, New York, 14642
LSU Health Sciences Center, Feist Weiller Cancer Center
Shreveport, Louisiana, 71130
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Stanford University Division of Oncology
Stanford, California, 94305
Arizona Cancer Center
Tucson, Arizona, 85724
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2: 4M1
Hopital du Sacre Couer de Montreal
Montreal, Quebec, H4J 1C5
Ottawa Hospital - General Campus
Ottawa, Ontario, KIH8L6
Saskatchewan Cancer Center Agency
Saskatoon, Saskatchewan, S7N 4H4
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Puerto Rico1 site
Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center
San Juan, 00919
About this study
Official title: A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Bendamustine HCl
- Keywords
- Lymphoma, Non-Hodgkin, Rituximab Refractory, Rituximab Failure, Indolent Non-Hodgkins Lymphoma
- 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 HClDrug
Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | bendamustine Receives: Drug: Bendamustine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy.
Measured: 6 months
Secondary outcomes (1)
• assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startOct 2005
- Primary completionJul 2007
- Study completionOct 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139841
- Sponsor's protocol ID
- SDX-105-03
- Status last verified
- May 2014
- First submitted
- 18 Aug 2005
- 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 III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
- ClinicalTrials.gov ID
- NCT00139841
- Acronym / sponsor ID
- SDX-105-03
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Lymphoma, Non-Hodgkin, Rituximab Refractory, Rituximab Failure, Indolent Non-Hodgkins Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Aug 2005 (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 a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
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 HClbendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented B-cell Non-Hodgkin's Lymphoma
- Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)
- Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
- Lymphoplasmacytic lymphoma
- Follicular center lymphoma, follicular
Key exclusion criteria (2 listed)
- Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible
- History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)
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 HClDose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles. | Drug | 1 |
Primary outcome
Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy.
Time frame: 6 months
1 secondary outcome
• assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations
Time frame: 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.
40 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bendamustine HCl in people with Non-Hodgkin's Lymphoma, run by Cephalon at 40 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 8 inclusion and 2 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 40 sites in United States, Canada, Puerto Rico. 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 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?
Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy. (time frame: 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.