TriangleNCT00139841 · CITED IN SOURCE DOCUMENTS
Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2014-05-09
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- ELIGIBILITY: Key Inclusion Criteria * 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 Key Exclusion Criteria * 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)
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- bendamustine
- intervention Names
- Drug: Bendamustine HCl
- label
- 1
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 1
- description
- 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.
- name
- Bendamustine HCl
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 103
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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
- secondary Outcomes
- measure
- • 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
Full study description
- brief 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®). 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.
Source references
Source notices and limitations
Discovery and provenance
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- stine Hydrochloride _ _ _ Chlorambucil Figure 1 14.2 Non-Hodgkin Lymphoma (NHL) The efficacy of bendamustine hydrochloride was evaluated in a single arm study (NCT00139841) of 100 patients with indolent B-cell NHL that had progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Patien
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Preserved source evidence · Not medical advice