At a glance
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RAVEN: A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
In Brief
A Phase 2 clinical trial evaluating Venetoclax, Navitoclax, and 15 other interventions for Refractory Acute Lymphoblastic Leukemia and Relapsed Acute Lymphoblastic Leukemia. Active but no longer recruiting, targeting 35 participants across 2 sites.
Detailed Summary
This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations with either blinatumomab for CD19-positive 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 relapsed or refractory acute lymphoblastic leukemia or lymphoma (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. Exploratory Objectives * To evaluate MRD-negative CR/CRi rates in each prespecified groups: late first relapse B-ALL; early first relapse and second or greater relapse B-ALL; and relapsed T-ALL. * To identify drug sensitivity patterns in patient samples prior to and after receiving combination therapy and evaluate mechanisms of disease resistance/ escape. * To explore immune subsets during and after this regimen. * Evaluate response to therapy in rare relapse patient subsets. * Explore breakthrough infections in children and young adults with relapsed or refractory ALL
Study Details
Timeline
Interventions
Given oral (PO).
Given oral (PO).
Given orally (PO) or intravenously (IV).
Given intravenously (IV).
Given intravenously (IV).
Given oral (PO).
Given intravenously (IV) or Intrathecal (IT).
Given intravenously (IV).
Given intravenously (IV), oral (PO), or Intrathecal (IT).
Given oral (PO).
Given intravenously (IV).
Given intravenously (IV).
Given oral (PO) or intravenously (IV).
Given Intrathecal (IT).
May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM).
To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
See detailed description section.