Low Grade B Cell Lymphoma
Conditions
Keywords
B cell, lymphoma
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.
Interventions
DRUGVTX-2337 plus radiotherapy
Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
Sponsors
Stanford University
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Assess the Safety and Feasibility of the Combination Regimen. | Safety assessed throughout study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VTX-2337 Plus Radiation VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | VTX-2337 Plus Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.
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.
Time frame: Tumor assessment conducted at 12 weeks and every 3-6 months thereafter
Population: Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VTX-2337 Plus Radiation | Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation. | 1 participants |
Secondary
Assess the Safety and Feasibility of the Combination Regimen.
Time frame: Safety assessed throughout study period.