Two-Arm Parallel Phase 2 Clinical Trial of Atezolizumab With or Without Low Dose Local Radiotherapy (2 x 2Gy) in Patients With Relapsed/Refractory Advanced Stage Follicular Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- atezolizumab
- Conditions
- Lymphoma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 2
- Locations
- 6
- Primary Endpoint
- Objective Response Rate
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and effects of atezolizumab with low dose radiation on people with relapsed or refractory follicular lymphoma, In this study, the patient will get either atezolizumab with low dose radiation or, atezolizumab alone. To be better, the atezolizumab and low dose radiation should increase life by 1 year or more compared to the usual approach.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form (ICF) Ability and willingness to comply with the requirements of the study protocol
- •Age ≥ 18 years
- •Relapsed or refractory follicular lymphoma grade 1, 2, or 3A
- •Relapsed disease is defined as having relapsed after greater than 6 months of prior treatment for follicular lymphoma
- •Refractory disease is defined as failure to achieve a complete response or relapsed within 6 months of treatment for follicular lymphoma
- •Pretreatment biopsy for fresh tumor tissue collection is required
- •If patient has recently undergone a biopsy and has not received any intercurrent anti-lymphoma therapy, archival tissue can be used
- •Stage III/IV disease
- •° Stage II disease is also eligible if disease is not encompassible within a single radiation field, as determined by the radiation oncologist
- •At least 1 prior treatment for follicular lymphoma (no restriction to number or type of prior therapies)
Exclusion Criteria
- •Follicular lymphoma grade 3B
- •Concurrent aggressive non-Hodgkin lymphoma (e.g. diffuse large B cell lymphoma \[DLBCL\])
- •Any anticancer therapy, including chemotherapy, hormonal therapy, investigational therapy, or radiotherapy, within 3 weeks, or 5 half lifes, whichever is shortest, prior to initiation of study treatment. However, the following are allowed:
- •Hormone-replacement therapy or oral contraceptives
- •Herbal therapy, provided it is discontinued at least 1 week prior to Cycle 1, Day 1
- •Palliative radiotherapy for bone metastases, provided most recent fraction not given within 2 weeks of Cycle 1, Day 1 and most recent fraction was not administered to planned area of radiation while on study.
- •AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 with exception of alopecia or skin/nail hyperpigmentation
- •Bisphosphonate therapy for symptomatic hypercalcemia within 2 weeks of cycle 1, day 1
- •° Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed. Denosumab should not be used while on therapy
- •Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
Arms & Interventions
atezolizumab
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
Intervention: atezolizumab
atezolizumab plus low-dose, local radiotherapy
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
Intervention: atezolizumab
atezolizumab plus low-dose, local radiotherapy
All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
Intervention: Low- Dose, Local Radiotherapy
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 3 years
objective response defined as CR or PR; as measured in non-irradiated sites of disease. Response will be assessed by the investigator per the Lugano Classification.