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

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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)

2 participants in 1 patient group

VTX-2337 plus radiation
Other group
Treatment:
Drug: VTX-2337 plus radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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