NCT05157971

Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia

Active, Not Recruiting
PHASE1Ages 18–54InterventionalTreatment
City of Hope Medical Center
~24 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:CyclophosphamideCytarabineDaunorubicin HydrochlorideMercaptopurineMethotrexatePegaspargase

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 30 days after completion of treatment
+1 more outcome measured
B Acute Lymphoblastic Leukemia
Ph-Like Acute Lymphoblastic Leukemia

NCT05157971

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical Center

    Duarte, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Ibrahim T Aldoss · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Documented informed consent of the participant and/or legally authorized representative
Age between 18 and 54 years
Eastern Cooperative Oncology Group (ECOG) =\< 2
Histologically confirmed B-cell ALL according to World Health Organization criteria
Note: Lymphoblastic leukemia is included as long as there is bone marrow involvement
Newly diagnosed disease with \>= 5% blasts in the marrow
White blood cell count less than 25 x 10\^9/L prior to initiation of venetoclax. Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease or underlying leukemia, =\< 3 X ULN) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
Aspartate aminotransferase (AST) =\< 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
Unless it is related to underlying leukemia
Alanine aminotransferase (ALT) =\< 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
Unless it is related to underlying leukemia
Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
Left ventricular ejection fraction (LVEF) \>= 50%
Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. (performed within 14 days prior to Day 1 of protocol therapy unless otherwise stated)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential\* to use an effective method of birth control (non-hormonal) or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only

Exclusion

Leukemia-based therapy with chemotherapy with the exception of:
Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
Strong or moderate CYP3A4 inducers within 14 days prior to day 1 of protocol therapy
Subjects who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the first dose of study drug
Live vaccines
Philadelphia chromosome positive (Ph+; t(9;22)), MLL-rearrangement, t(12;21), and t(1;19)
T cell ALL
Class III/IV cardiovascular disability according to the New York Heart Association Classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll
Parenchymal central nervous system (CNS) involvement requiring cranial radiation
Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment
History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Uncontrolled active infection
Other active malignancy
Females only: Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
  • Incidence of adverse eventsUp to 30 days after completion of treatment

    Will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome.

  • Dose limiting toxicityDuring cycle 1 (4 weeks)

    Defined as any toxicities that occur during cycle 1, per CTCAE version 5.0, and are considered at least possibly related to venetoclax or the combination of venetoclax and C10403. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome.