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| Name | Class |
|---|---|
| Kite, A Gilead Company | INDUSTRY |
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This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous CAR T-cell immunotherapy | Experimental | Tecartus will be delivered at a target dose of 1x106 cells / kg. For those >100 kg, a flat dose of 1 x108 cells will be used. Tecartus will be administered on day 0, following 1 day of rest from conditioning chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecartus | Drug | Tecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival (RFS) | The primary endpoint is RFS, defined as the time from KTE-X19 infusion until clinical relapse or death from any cause. Patients proceeding to subsequent anti-cancer therapy, inclusive of allogeneic transplantation, without relapse will be censored in this analysis. Surviving patients not meeting criteria for relapse by the analysis data cutoff date will be censored at their last evaluable disease assessment date. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular Response Rate | Measured as converting to a complete molecular remission following CAR T-cell immunotherapy. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells. | Up to 5 years |
| Clinical Relapse Rate |
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Inclusion Criteria:
A. Vincristine associated grade 1 peripheral neuropathy B. Steroid/asparaginase associated diabetes and/or hypertension C. Inotuzumab/chemotherapy associated cytopenias
Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow biopsy with fewer than 5% lymphoblasts. Complete remission implies the resolution of any extramedullary and/or Central Nervous Syndrome (CNS)-2-3/parenchymal disease.
Be willing and able to provide written informed consent/assent for the trial.
Able to adhere to the study visit schedule and other protocol requirements.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Adequate renal, hepatic, pulmonary, cardiac function.
Adequate hematopoietic reserve.
Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female:
1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
Subjects of both genders of child-bearing potential must be willing to practice birth control from the time of consent through 6 months after the completion of KTE-X19 infusion.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Connor Tate | Contact | 813-745-3783 | ICETtrials@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Bijal D. Shah, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000705347 | brexucabtagene autoleucel |
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|
Measured as >5% lymphoblasts in the bone marrow and/or the emergence of extramedullary leukemia. |
| Up to 5 years |
| Molecular Relapse Rate | Measured as achieving complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells. | Up to 5 years |
| Duration of Response (DOR) | Measured as time from enrollment until clinical relapse or death. In the case of death without documented relapse, patients will be censored. | Up to 5 years |
| Molecular Relapse Free Survival (MRFS) | Measured by complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells. | Up to 5 years |
| Overall Survival | Measured as time from date of enrollment to date of death from any cause. | Up to 5 years |
| Rate of Cytokine Release Syndrome (CRS) | Participants rate of developing Cytokine Release Syndrome (CRS) | Up to 5 years |
| Rate of Immune effector cell-associated neurotoxicity syndrome (ICANS) | Participants rate of developing Immune effector cell-associated neurotoxicity syndrome (ICANS). | Up to 5 years |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |