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| ID | Type | Description | Link |
|---|---|---|---|
| CCT5065 | Other Identifier | Stanford Cancer Center |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
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In this study, invesigators propose to analyze 150 DLBCL patients, 50 MCL patients, and 100 FL patients to determine the clinical utility of ctDNA- as well as circulating tumor cell (CTC)-based MRD assessment in CAR therapy patients. The project detailed in this protocol will utilize the clonoSEQ platform as specific quantification of residual DLBCL/FL/MCL and correlate its results with radiologic assessment of disease and clinical outcomes. Invesitgators predict there will be a strong correlation between ctDNA and PET/CT and dynamic changes in ctDNA will precede radiologic evidence of disease recurrence in patients following CAR therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | For DLBCL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, and potentially at relapse following CAR infusion. For DLBCL, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells |
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| Follicular Lymphoma | For FL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, Day+365, and potentially D+547 and at relapse following CAR infusion. For FL patients, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells |
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| Mantle Cell Lymphoma | For MCL patients, prospective blood samples will be collected, in provided collection kits, at: pre-lymphodepletion chemotherapy, Day+14, Day+28, Day+90, Day+180, Day+365, and potentially D+547 and at relapse following CAR infusion. For MCL patients, PET/CT scan images done prior to CAR19 therapy, Day 28 post-infusion, 3 months post-infusion, and 6 months post-infusion of CAR19 cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClonoSEQ | Device | Cancer clonotype sequences are identified in diagnostic 'ID' samples and then sequence frequencies are measured in follow up samples. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome: Predicting Progression Free Survival | Ability of ctDNA MRD assessment to predict progression-free survival (PFS) at 6 months following CAR infusion in DLBCL, FL and MCL patients. | 0-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objective: Correlation of minimal residual disease and tumor burden | -Determine the correlation between quantified MRD and metabolic tumor volume (MTV) | 0-18 months |
| Secondary Objective continued: Looking at clinical information of minimal residual disease |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects ≥ 18 years of age, with DLBCL, FL, or MCL who are undergoing standard-of-care CAR therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi Simmons, PhD | Contact | 206-279-2591 | hsimmons@adaptivebiotech.com | |
| Monica Gallucci | Contact | mgallucci@adaptivebiotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Heidi Simmons, PhD | Adaptive Biotechnologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Recruiting | Palo Alto | California | 94306 | United States |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Patients will prospectively have blood samples collected prior to lymphodepleting chemotherapy and during the first 6-12 months after CAR infusion for MRD analysis. Patients will have their original tissue biopsy or bone marrow (which shows evidence of disease) analyzed to determine their clonotype for future assessments on peripheral blood sample.
-Determine the clinical utility of MRD assessments in an exploratory analysis |
| 0-18 months |
| Secondary Objective continued: Additional correlations | -Determine the correlation between ctDNA-based and CTC-based MRD assessments in DLBCL/FL/MCL | 0-18 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |