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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Cytarabine; Daunorubicin; Venetoclax

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