Status:
RECRUITING
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Leukemia
Eligibility:
All Genders
1-39 years
Phase:
PHASE1
Brief 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 treatmen...
Detailed 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 r...
Eligibility Criteria
Inclusion
- Ages 1 Year to 39 Years
- Diagnosis of one of the following:
- Acute myeloid leukemia (AML), any subtype except
- Patients with acute promyelocytic leukemia (APML) are NOT eligible
- Patients with ML-DS are NOT eligible
- Myeloid sarcoma
- Acute leukemia of ambiguous lineage (ALAL)
- Acute undifferentiated leukemia (AUL)
- T/myeloid mixed phenotype acute leukemia (MPAL)
- B/myeloid MPAL
- MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible
- T-cell acute lymphoblastic leukemia (T ALL)
- Early thymocyte precursor (ETP) ALL
- KMT2A-rearranged ALL
- Disease Status
- Relapsed/Refractory AML, MPA, and AUL
- Untreated therapy related AML
- Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP 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
- Diagnosis of one of the following:
- Myeloid Leukemia associated with Down Syndrome (ML-DS)
- Acute Promyelocytic Leukemia (APML)
- Acute leukemia with CNS status 3 involvement
- Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, 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
- 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
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03826992
Start Date
December 27 2018
End Date
January 1 2028
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229