Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase 2 study tests how well KTE-X19 CAR T-cell therapy works and how safe it is. It is for adults with B-cell acute lymphoblastic leukemia (B-ALL) who are in remission after their first chemotherapy but still have small amounts of cancer left.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and have confirmed B-ALL with a marker called CD19 on the cancer cells.
- Have recovered from the first round of chemotherapy. Some treatment-related nerve problems, diabetes, high blood pressure, or low blood cell counts are allowed.
- Be in complete remission with small amounts of cancer left: fewer than 5% leukemia cells in a bone marrow sample. Cancer outside the bone marrow, including in the brain or spinal cord, must have cleared.
- Be fully active or able to do light work, with limits only on hard physical activity.
- Have kidneys, liver, lungs, and heart that work well enough, and enough ability to make blood cells.
- Be willing and able to give written consent and follow study visits and rules.
- Have a negative blood pregnancy test at screening if able to become pregnant.
- Use birth control, if able to have children, from consent until 6 months after the KTE-X19 infusion.
Who can't join
- Have certain other blood cancers, including L3 Burkitt lymphoma, MLL-rearranged leukemia, mixed-type leukemia, blast-phase chronic myeloid leukemia, or stem-cell leukemia.
- Have an active infection needing treatment throughout the body, including HIV or hepatitis B or C; another active, uncontrolled or spreading cancer; or a serious illness with an expected lifespan under 6 months.
- Have repeated blood clots, or a clot not linked to a central vein catheter in the past 3 months. Have had a heart attack, heart artery procedure, unstable chest pain, or other major heart disease in the past 12 months.
- Have a past or current brain or nervous system disorder, such as seizures, stroke, dementia, or brain swelling; or active leukemia in the brain, spinal cord, or their lining.
- Have an inherited condition causing bone marrow failure, an immune system weakness present from birth, or an autoimmune disease that damaged organs or needed body-wide immune-suppressing treatment in the past 2 years.
- Use more than 5 mg of prednisone daily, an equal dose of another steroid, or other immune-suppressing drugs within 7 days before enrollment. Have received a live vaccine within 4 weeks before enrollment.
- Have a tube or drain left in the body, except an Ommaya reservoir or a dedicated central vein catheter. Other health problems, treatments, or test results may also prevent joining if the study doctor thinks participation is unsafe or could affect results.
- Be pregnant or breastfeeding, or plan to become pregnant or father a child from screening through 3 months after the last study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. 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: * 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 the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severe Congestive Heart Failure (CHF). * 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 syndrome (PRES), or cerebral edema. * 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 last 2 years. * 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 catheters such as a Port-a-Cath or Hickman catheter are permitted. * 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.
Study sites (1)
FL
- Moffitt Cancer Center · Tampa, FL 33612Bijal D. Shah, MD · Principal investigatorRawan Faramand, MD · Sub-investigatorLeidy Isenalumhe, MD · Sub-investigatorFrederick Locke, MD · Sub-investigatorMore trials in Tampa