Acute Myeloid Leukemia Clinical Trial

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

Summary

This 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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Full Description

This is a single-institution Phase I pilot study designed to test the safety and tolerability of combining venetoclax with Vyxeos (CPX-351, cytarabine and daunorubicin liposome) for the treatment of relapsed/refractory acute leukemia in young patients. Subjects will receive a single course of study therapy consisting of daily, oral venetoclax at an assigned dose level with a 3-day ramp-up to target dose and Vyxeos administered intravenously at the established dose on Days 1, 3, and 5. In addition to safety and tolerability, the overall response rate to these therapies will be estimated. Pharmacokinetic (PK) analysis will also be conducted to define the drug clearance of venetoclax in this combination.

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Eligibility Criteria

Inclusion Criteria:

Ages 1-39 years

Diagnosis of one of the following:

Acute myeloid leukemia (AML)
Acute undifferentiated leukemia (AUL)
Mixed phenotype acute leukemia (MPAL)
T-cell acute lymphoblastic leukemia (T ALL)
Early thymocyte precursor (ETP) ALL
KMT2A-rearranged ALL

Disease status

Relapsed/Refractory AML, MPAL and AUL
Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETP ALL
Karnofsky/ Lanksy performance level score of greater than or equal to 50 percent

Prior therapy requirements

Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure
14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine
2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone marrow radiation
Adequate renal, liver, cardiac and central nervous system (CNS) function

Exclusion Criteria:

Diagnosis of one of the following:

Acute Promyelocytic Leukemia (APML)
Acute leukemia with CNS status 3 involvement
Philadelphia chromosome positive leukemia (Ph+ ALL, MPAL, or AUL)
Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder
Wilson's Disease or other copper-metabolism disorder
Pregnant or breastfeeding
Uncontrolled infection
Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum
Unable to swallow tablets
Receipt of growth factors within 7 days prior to enrollment
Currently receiving another investigational drug
Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea)
Unable to comply with the safety monitoring requirements of the study

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT03826992

Recruitment Status:

Suspended

Sponsor:

Children's Hospital Medical Center, Cincinnati

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There is 1 Location for this study

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Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT03826992

Recruitment Status:

Suspended

Sponsor:


Children's Hospital Medical Center, Cincinnati

How clear is this clinincal trial information?

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