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Phase I Study of Hyper-CVAD and Venetoclax for Relapsed/Refractory Acute Leukemias

This study is testing a combination of two drugs, Hyper-CVAD (given intravenously, into a vein) and Venetoclax (given by mouth), for children and young adults aged 2 to 21 with acute leukemia that has come back (relapsed) or hasn't responded to previous treatments (refractory). This includes specific types of leukemia called lymphoid, bi-phenotypic, or undifferentiated leukemias. The main goal is to find the safest and most effective dose of this drug combination. Researchers will also look at how safe the treatment is and if it helps shrink the leukemia. The study plans to enroll 22 participants, but its current status is unclear.

Study design
This is a Phase I interventional study aiming to find the recommended dose of the drug combination. It plans to enroll 22 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06466395

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

Recruiting
PHASE1Ages 2–21InterventionalTreatment
M.D. Anderson Cancer Center
~22 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:VenetoclaxHyper-CVAD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Refractory Acute Leukemia
Relapsed Acute Leukemia
Undifferentiated Leukemia
Bi-Phenotypic Leukemia

Explore related trials

Acute LeukemiaMouse Bi-phenotypic LeukemiaUndifferentiated leukemia

NCT06466395

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.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

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

Study leadership

  • David McCall, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

David McCall, MD
[email protected]
(713) 792-6604
Email the study team

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Eligibility criteria

Inclusion

During times of dexamethasone dosing (cycles 1,3,5 and 7): Hold chronic steroids on days dexamethasone is given then resume normally scheduled chronic steroid dosing the following day.
Participants on chronic steroids \> 11.6mg/m2 (20 mg max) prednisone equivalent will be excluded from the study. 2. The use of topical steroids for cutaneous graft-versus-host disease (GVHD) is allowed. 3. Participants should be at least 2 weeks or 5 half-lives (whichever is longer) from prior therapy, other than hydroxyurea, glucocorticoids or low dose cytarabine (as mentioned above) to maintain blast count prior to initiation of study therapy. 6. Participants must have adequate organ function and laboratory results (obtained within 14 days of enrollment):
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 7. 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. 8. 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. 9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 10. 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. 11. Ability to understand and the willingness to sign a written informed consent document. 12. Participants with CD19+ B-ALL need to have received CD19-directed therapy prior to being considered for enrollment on this study.

Exclusion

curatively treated non-melanomatous skin cancer,
other primary solid tumor treated with curative intent and no known active disease present, and no treatment administered during the last 2 years. 2. Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0