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| Name | Class |
|---|---|
| Blood and Marrow Transplant Group of Georgia | OTHER |
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This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Renal Dysfunction | Experimental | Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide. |
|
| Severe Renal Dysfunction | Experimental | Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide. |
|
| Dialysis Participants | Experimental | Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Received IV on Days -5 to -3 before CAR T cell therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of CRS | Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion | 90 days |
| Occurrence of ICANS | Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion | 90 days |
| Occurrence of Cytopenias | Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melhem Solh, MD | Contact | 404-255-1930 | msolh@bmtga.com | |
| Caitlin Guzowski, MBA, MHA | Contact | 404-851-8523 | caitlin.guzowski@northside.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caitlin Guzowski | Recruiting | Atlanta | Georgia | 30342 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide | Drug | Received IV on Days -5 to -3 before CAR T cell therapy |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D008206 | Lymphatic Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |