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SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon ) Identifier:
First received: January 20, 2004
Last updated: May 8, 2014
Last verified: May 2014


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.


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.


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.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Drug: bendamustine and rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries ( Cephalon ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • • 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 ]

Enrollment: 66
Study Start Date: April 2004
Study Completion Date: March 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab
Drug: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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)


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00076349

  Show 34 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Cephalon Identifier: NCT00076349     History of Changes
Other Study ID Numbers: SDX-105-02
Study First Received: January 20, 2004
Last Updated: May 8, 2014

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
Non-Hodgkin's Lymphoma
Mantle Cell

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017