RECRUITING

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

Conditions

Leukemia relapsed refractory Vyxeos Venetoclax acute myeloid leukemia acute myeloid leukemia, childhood mixed-lineage leukemia (MLL)AML CPX-351 Venclexta Histone-lysine N-methyltransferase 2A (KmT2A)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Study of Venetoclax Combined With Vyxeos (CPX-351) for Children, Adolescents and Young Adults With Relapsed or Refractory Acute Leukemia

Quick Facts

Study Start:2018-12-27

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03826992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Site Pulblic Contact

CONTACT

513-636-2799

cancer@cchmc.org

Principal Investigator

John Perentesis, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

John Perentesis, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-27

Study Completion Date2026-01

Study Record Updates

Study Start Date2018-12-27

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

relapsed
refractory
Vyxeos
Venetoclax
acute myeloid leukemia
acute myeloid leukemia, childhood
mixed-lineage leukemia (MLL)
AML
CPX-351
Venclexta
Histone-lysine N-methyltransferase 2A (KmT2A)

Additional Relevant MeSH Terms

Leukemia