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OncoMatch/Clinical Trials/NCT03826992

Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

Is NCT03826992 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Vyxeos and Venetoclax for leukemia.

Phase 1RecruitingChildren's Hospital Medical Center, CincinnatiNCT03826992Data as of Jun 2026

Treatment: Vyxeos · VenetoclaxThis study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Venetoclax

Other

Vyxeos

Biomarker criteria

Required: KMT2A (MLL) rearranged

KMT2A-rearranged ALL

Excluded: KMT2A (MLL) rearrangement

MPAL with KMT2A-rearrangement are NOT eligible

Excluded: BCR t(9;22)

Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)

Demographics

Ages 1–39

Prior therapy

Must have received: hematopoietic stem cell transplant

Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT)

Must have received: anthracycline

Fully recovered from acute toxicities of ... Anthracycline Exposure

Cannot have received: growth factors

Receipt of growth factors within 7 days prior to enrollment

Cannot have received: radiation therapy

Exception: greater than 13.6 Gray (Gy) prior radiation to the mediastinum

Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum

Lab requirements

Kidney function

adequate renal function

Liver function

adequate liver function

Cardiac function

adequate cardiac function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT03826992 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior growth factors, radiation therapy disqualifies patients from enrollment.

Does this trial require KMT2A?

Yes, KMT2A rearranged is a required biomarker for enrollment.

Are patients with KMT2A alterations eligible?

No. KMT2A rearrangement is an exclusion criterion.

Are patients with BCR alterations eligible?

No. BCR t(9;22) is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 39 years or younger and at least 1 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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