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

Sponsored by:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00076349

Purpose

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.

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

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bendamustine Rituximab 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 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)

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Enrollment:	66
Study Start Date:	April 2004
Estimated Study Completion Date:	July 2010
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076349

Show 34 Study Locations

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	SDX-105-02
Study First Received:	January 20, 2004
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00076349 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

Non-Hodgkin's Lymphoma
NHL
Rituxan
Mantle Cell
mabs

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Immunologic Factors
Rituximab

Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Bendamustine

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Rituximab
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Bendamustine

ClinicalTrials.gov processed this record on May 07, 2009