Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Bendamustine HCl	Phase III

MedlinePlus related topics:

Cancer Lymphoma

ChemIDplus related topics:

Rituximab Bendamustine Bendamustine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy 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

Further study details as provided by Cephalon:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• 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 ] [ Designated as safety issue: Yes ]

Enrollment:	103
Study Start Date:	October 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental bendamustine	Drug: Bendamustine HCl 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139841

Show 40 Study Locations

Sponsors and Collaborators

Cephalon

More Information

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	SDX-105-03
First Received:	August 18, 2005
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00139841
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

Lymphoma, Non-Hodgkin

Rituximab Refractory

Rituximab Failure

Indolent Non-Hodgkins Lymphoma

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Rituximab

Mechlorethamine

Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Nitrogen Mustard Compounds

Bendamustine

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Alkylating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00139841