A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed … (NCT06466395) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias
United States22 participantsStarted 2025-02-18
Plain-language summary
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
Who can participate
Age range2 Years – 21 Years
SexALL
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Inclusion criteria
✓. Relapsed/refractory leukemias as defined as:
✓. Pediatric, adolescent, or young adult patients with relapsed or refractory acute leukemias that are of the lymphoid lineage including bi-phenotypic or undifferentiated leukemias as per NCCN v2.2021 and W.H.O. classification in relapse or primary refractory.
✓. Participants must have ≥5% blasts in the bone marrow as assessed by morphology. However, if an adequate bone marrow sample cannot be obtained, patients may be enrolled if there is unequivocal evidence of leukemia with ≥5% blasts in the peripheral blood.
✓. Participants have adequate performance status (ECOG ≤2) for patients ≥16 years old, Lansky score \>50 for patients \<16 years old.
✓. Participants must be ≥ 2 years old or less than or equal to 21 years of age at time of signing/or having proxy sign the informed consent to be enrolled on study.
✓. Participants with asymptomatic CNS disease are eligible.
✓. These conditions are allowed on study: conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease, graft versus host disease (GVHD) (well controlled on a stable dose of steroid or alternative therapy) or severe asthma. Participants are also allowed up to 5 days of glucocorticoids as cytoreduction, the use of hydroxyurea and the usage of cytarabine up to 2gm/m2. This should also be discussed with PI.
✓. For participants on chronic glucocorticoid therapy: Participants should be on stable systemic steroid doses less than or equal to 11.6mg/m2 (20 mg max) of prednisone daily
Exclusion criteria
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.
. Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 30 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 30 days after the last treatment.
✕. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of all study drug administration. Participants must have had at least 30 days between prior hematopoietic stem cell transplant and first dose of study drug.
✕. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
✕0. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
✕1. Ability to understand and the willingness to sign a written informed consent document.
✕2. Participants with CD19+ B-ALL need to have received CD19-directed therapy prior to being considered for enrollment on this study.
✕. Past or current history of a secondary or other primary tumor or a chronic myeloid leukemia (CML) blast crisis with exception of:
✕. Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.