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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00076349
Registration number
NCT00076349
Ethics application status
Date submitted
20/01/2004
Date registered
22/01/2004
Date last updated
9/05/2014
Titles & IDs
Public title
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)
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Scientific 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)
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Secondary ID [1]
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SDX-105-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bendamustine and rituximab
Experimental: 1 - open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
Treatment: Drugs: bendamustine and rituximab
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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4-6 months
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Secondary outcome [1]
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• 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)
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Assessment method [1]
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Timepoint [1]
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4-6 months
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Eligibility
Key inclusion criteria
INCLUSION CRITERIA:
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)
EXCLUSION CRITERIA:
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Institute - East Melbourne
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Recruitment hospital [2]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [3]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [4]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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8006 - East Melbourne
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment postcode(s) [3]
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NSW 2010 - Darlinghurst
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Recruitment postcode(s) [4]
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NSW 2145 - Westmead
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Recruitment outside Australia
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United States of America
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Alaska
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United States of America
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California
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Connecticut
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District of Columbia
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Florida
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United States of America
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Georgia
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Indiana
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United States of America
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New York
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Tennessee
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Texas
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Virginia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cephalon
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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). 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00076349
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00076349
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