Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05591 | Registry Identifier | NCI- Clinical Trial Reporting Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kite, A Gilead Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the feasibility of oral dasatinib pulses (3 consecutive days per week) during the first month following infusion of brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib | Experimental | Oral dasatinib 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | 3 pulses of oral dasatinib (100 mg daily) beginning on Day 4 (+up to 2 days) for 3 days (with 4 days off), repeated weekly. The weekly 3-day pulse schedule of dasatinib may continue for up to 3 months in subjects who continue to meet the dasatinib eligibility criteria and who do not meet off treatment/off study criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of dasatinib pulses | Feasibility of administering oral dasatinib pulses (3 consecutive doses per week) during the first month following Tecartus infusion. Feasibility will be defined as the ability of 8 out of 20 subjects to miss no more than one cycle (defined as one week of at least three consecutive days of dasatinib) within the first month following Tecartus infusion. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of oral dasatinib pulses | Defined by a description of adverse events and serious adverse events at least possibly related to dasatinib following CAR T cell therapy; it will include an analysis of the sequential toxicity boundaries in that the analysis does not lead to a pause in the study; further defined as no reports of suspected death on study. | 2 years |
Not provided
Inclusion Criteria:
Relapsed or refractory B-precursor ALL defined as one of the following:
Primary refractory disease (>=5% blasts or persistent extramedullary disease following induction therapy)
First or later relapse of marrow or extramedullary disease
Persistence of MRD defined as detectable ALL by flow cytometry, PCR, or next-generation sequencing
Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from transplant at time of enrollment
Patients with isolated, asymptomatic CNS relapse will be eligible
Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min
Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome.
Cardiac ejection fraction ≥ 50%, no evidence of clinically significant pericardial effusion, and no clinically significant arrhythmias
Baseline oxygen saturation > 92% on room air
QTc ≤ 500ms
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lori Muffly, M.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Overall response rate | The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2). | 3 months |
| Complete Response (CR) | The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2). | 3 months |
| MRD-negative Complete Response (CR) | The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2). | 3 months |
| Duration of CR in responders | 2 years |
| Progression Free Survival (PFS) following Tecartus plus dasatinib | PFS is defined as the time from the start of the investigational therapy to the date of radiographic progression | 2 years |
| Overall Survival (OS) following Tecartus plus dasatinib | OS is defined as the time from the date of initial disease diagnosis to the date of death from any cause | 2 years |
| D006425 |
| Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |