Actively Recruiting
Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
60
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
K
Kite, A Gilead Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, except for mild vincristine-associated peripheral neuropathy, steroid/asparaginase associated diabetes or hypertension, or chemotherapy-related low blood counts.
- In complete remission with minimal residual disease defined as fewer than 5% lymphoblasts in bone marrow biopsy.
- Resolution of any extramedullary or CNS disease.
- Willing and able to provide written informed consent.
- Able to follow study visit schedule and protocol requirements.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate kidney, liver, lung, heart function.
- Adequate blood cell production.
- Females of childbearing potential must have a negative pregnancy test at screening.
- Subjects of child-bearing potential must agree to use birth control from consent through 6 months after treatment.
You will not qualify if you...
- Diagnosis of L3 type Burkitt's lymphoma, mixed-lineage leukemia, biphenotypic leukemia, mixed phenotype acute leukemia, blast phase of chronic myeloid leukemia, or stem-cell leukemia.
- Any active infection needing systemic therapy including HIV, hepatitis B or C.
- Conditions or treatments that might interfere with participation or study results, such as unstable angina, liver disease, pancreatitis, uncontrolled diabetes, pulmonary hypertension, or severe heart failure.
- Recurrent or recent thrombosis within 3 months.
- Significant cardiac events or disease within 12 months.
- History or presence of CNS disorders including seizure, stroke, dementia, autoimmune CNS disease, posterior reversible encephalopathy syndrome, or cerebral edema.
- Active CNS or leptomeningeal leukemia.
- Severe illnesses with life expectancy less than 6 months.
- Active uncontrolled metastatic second cancers.
- Genetic syndromes causing bone marrow failure.
- Primary immunodeficiency or autoimmune disease causing organ injury or needing systemic immunosuppression within 2 years.
- Use of corticosteroids or immunosuppressive drugs within 7 days prior to enrollment.
- Presence of indwelling lines or drains except certain central venous catheters.
- Live vaccine within 4 weeks prior to enrollment.
- Pregnant, breastfeeding, or planning to conceive or father children during the study and for 3 months after treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
C
Connor Tate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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