VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

Celgene

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Low Grade B Cell Lymphoma

Treatments: Drug: VTX-2337 plus radiotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01289210

VRXP-A104

Details and patient eligibility

About

This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• low grade B cell lymphoma
• 1 or more sites of disease appropriate for intratumoral injection
• measurable disease other than the injection site
• Performance Status of 1 or better
• Adequate bone marrow, renal and hepatic function
• No active autoimmune disease or systemic immunosuppressive drugs
• Life expectancy > 4 months

Exclusion Criteria:

• Known HIV
• Known brain metastases
• Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK)
• Anticoagulation therapy other than 325mg QD ASA
• Significant cardiovascular disease
• Pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

VTX-2337 plus radiation

Other group

Treatment:

Drug: VTX-2337 plus radiotherapy