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RAVEN: Clinical Trial to Treat Relapsed Acute Lymphoblastic Leukemia with Venetoclax and Navitoclax

A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia with Venetoclax and Navitoclax

Category:

Leukemia / Lymphoma

Diseases Treated:

Acute Lymphoblastic Leukemia and Lymphoma

Eligibility Overview:

  • Diagnosed with relapsed or refractory acute lymphoblastic leukemia or lymphoma
  • Between 4 and 22 years old
  • Weigh more than 20 kg (44.09 lbs.)
  • Able to swallow pills
  • No prior exposure to navitoclax
  • Fully recovered from effects of any prior treatment

 

  1. Brief Summary

    This is a phase I/II clinical trial to evaluate the activity of combination chemotherapy with venetoclax and navitoclax in children and young adults with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL). It will also assess the combination dose of venetoclax combinations with either blinatumomab for CD19-postive patients or navitoclax and high-dose cytarabine for CD19-negative patients. 

    In Block I, all patients receive common therapy evaluating the activity of combination chemotherapy with venetoclax and navitoclax.

    In Block 2, a phase 1 rolling six design and phase 2 extension will be used to assess the combination dose of venetoclax combinations with either blinatumomab for CD19-postive patients or navitoclax and high-dose cytarabine for CD19-negative patients.

    Primary Objectives

    • To compare minimal residual disease (MRD)-negative CR/CRi rate in children with rALL following Block 1 therapy with venetoclax and navitoclax-based reinduction to historical controls.
    • To identify the recommended phase 2 combination dose (RP2D) of venetoclax-based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab.

    Secondary Objectives

    • To estimate the tolerability and activity of venetoclax-based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab.
    • To describe event-free and overall survival in patients treated with this regimen.

    Eligibility criteria

    Inclusion criteria include:

    • Diagnosed with relapsed or refractory acute lymphoblastic leukemia or lymphoma. Refractory disease is defined as residual leukemia ≥1% after at least 2 prior lines of frontline therapy with curative intent.
    • Between 4 and 22 years old
    • Weigh more than 20 kg (44.09 lbs.)
    • Able to swallow pills
    • No prior exposure to navitoclax
    • Fully recovered from effects of any prior treatment
    • Participants of reproductive age must use methods of birth control during the study and for at least 30 days after the last dose of treatment

    Exclusion criteria include:

    • HIV infection or active hepatitis B or C infection
    • Pregnant or lactating

    Study Sites

    • St. Jude Children’s Research Hospital, Memphis, Tennessee
    • Collaborating sites worldwide
  2. About this study

    This is a research study for patients who have acute lymphoblastic leukemia (ALL) that has come back after treatment (relapsed). Researchers want to find out if two new drugs called venetoclax and navitoclax are safe and if they are beneficial for children, adolescents and young adults when combined with chemotherapy.

    Venetoclax is approved by the U.S. Food and Drug Administration (FDA) to treat certain types of leukemia in adults. Venetoclax is not approved by the FDA for treating childhood leukemia. Navitoclax is not approved by the FDA.

    Purpose of this clinical trial

    The main goal of this study is to find out the good and bad effects of treatment with venetoclax and navitoclax when given with chemotherapy to children with relapsed and refractory ALL.

    Eligibility overview

    Inclusion criteria include:

    • Diagnosed with acute lymphoblastic leukemia or lymphoma that has come back
    • Between 4 and 22 years old
    • Weigh more than 20 kg (44.09 lbs.)
    • Able to swallow pills
    • Has not taken navitoclax in the past
    • Fully recovered from effects of any earlier treatment

    Exclusion criteria include:

    • HIV infection or active hepatitis B or C infection
    • Pregnant or breastfeeding
  3. RAVEN Quick View
    Sponsor St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT05192889
    Trial start date August 2022
    Estimated enrollment 90
    Study type Interventional
    Phase Phase 1/2
    Conditions

    Leukemia

    Ages 4 to 22 years old
    Principal investigators Seth Karol, MD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss RAVEN St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Seth Karol, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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