SDX-105 in Combination With Rituxan for 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.

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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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bendamustine and Rituximab

Drug

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.

Primary outcomes

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

Secondary outcomes

• 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

Sponsors and collaborators

Lead sponsor

Cephalon

Industry

Registry information

Official study 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)

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2008
First posted: Jan 22, 2004
Registry last updated: May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed