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

Cephalon

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: bendamustine and rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076349

SDX-105-02

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

1

Experimental group

Description:

open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab

Treatment:

Drug: bendamustine and rituximab