BridgeMD
New treatment option for B-Cell Lymphoblastic Leukemia
Official title Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
ClinicalTrials.gov ID: NCT06144606
What this study is testing
What is Tecartus?
Tecartus is an investigational medicine, being studied as a potential treatment for b-cell lymphoblastic leukemia.
Also referred to as Brexucabtagene autoleucel, KTE-X19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be an adult 18 years of age or older.
- Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia.
- Treatment and full recovery from induction chemotherapy, with following exceptions: A. Vincristine associated grade 1 peripheral neuropathy B...
- Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow...
- Be willing and able to provide written informed consent/assent for the trial.
You likely can't join if
- Diagnosis of L3 type Burkitt's lymphoma, Mixed-Lineage Leukemia (MLL) rearranged leukemia, biphenotypic leukemia, mixed phenotype acute leukemia...
- Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the...
- Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months...
- History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune...
See the full eligibility criteria
- Must be an adult 18 years of age or older.
- Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia.
- Treatment and full recovery from induction chemotherapy, with following exceptions: A. Vincristine associated grade 1 peripheral neuropathy B. Steroid/asparaginase associated diabetes and/or hypertension C...
- 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...
- 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)...
- people 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.
- Diagnosis of L3 type Burkitt's lymphoma, Mixed-Lineage Leukemia (MLL) rearranged leukemia, biphenotypic leukemia, mixed phenotype acute leukemia, blast phase of chronic myeloid leukemia, or stem-cell leukemia.
- Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in...
- Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3 months prior to enrollment.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
- History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy...
- Active CNS/leptomeningeal leukemia.
- Severe comorbid conditions for which life expectancy would be \<6 months.
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome.
- Primary immunodeficiency or history of autoimmune disease (Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the...
- Corticosteroid therapy at a pharmacologic dose (\> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment.
- Presence of any indwelling line or drain (percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access...
- Live vaccine ≤ 4 weeks prior to enrollment.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.