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

Phase 1

Terminated

• Conditions: Low Grade B Cell Lymphoma
• Interventions: Drug: VTX-2337 plus radiotherapy

• Registration Number: NCT01289210
• Lead Sponsor: Celgene

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Study Start: 2011-07
• Primary Completion: 2011-11
• Study Completion: 2012-10
• Results First Submitted: 2014-05-28
• Results First Submitted QC: 2014-09-29
• Results First Posted: 2014-10-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VTX-2337 plus radiation	VTX-2337 plus radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.	Tumor assessment conducted at 12 weeks and every 3-6 months thereafter	Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.

Secondary Outcome Measures

Name	Time	Method
Assess the Safety and Feasibility of the Combination Regimen.	Safety assessed throughout study period.

Trial Locations

Locations (1)

Stanford Cancer Center; 🇺🇸 Stanford, California, United States