A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Objectives: * Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML * Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: \- Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy
Eligibility
Participation Requirements
Sex: All
Minimum Age: 29 days
Maximum Age: 21
Healthy Volunteers: f
View:
• Diagnosis of AML fulfilling the criteria of the WHO classification of myeloid neoplasms or \< 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality or myeloid sarcoma or primary myelodysplastic syndrome (MDS) with ≥ 10% blasts or a complete blood count with the presence of at least 1,000 blasts/μL (e.g., a WBC count ≥ 10,000/μL with ≥ 10% blasts or a WBC count ≥ 5,000/μL with ≥ 20% blasts
• Age \> 28 days and \< 22 years
• No prior therapy for this malignancy except for one dose of intrathecal therapy and hydroxyurea or low-dose cytarabine (≤ 200 mg/m\^2 per day for ≤ 7 days)
• Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment
• Male and female participants of reproductive potential must agree to use an effective contraceptive method during the study and for 6 months after study treatment
• Written informed consent from the patient and/or parent/legal guardian
• Direct bilirubin ≤ 1.5 x institutional upper limit of normal
Locations
United States
California
Valley Children's Hospital
RECRUITING
Madera
Children's Hospital of Orange County
RECRUITING
Orange
Rady Children's Hospital-San Diego
RECRUITING
San Diego
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
North Carolina
Novant Health Presbyterian Medical Center
RECRUITING
Charlotte
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Contact Information
Primary
Hiroto Inaba, MD, PhD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date:2023-07-25
Estimated Completion Date:2034-03
Participants
Target number of participants:70
Treatments
Experimental: Low Risk
All eligible patients receive intervention according to the Detailed Description section with the following:~Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Etoposide, Mitoxantrone Hydrochloride, Gilteritinib
Experimental: Intermediate Risk
All eligible patients receive intervention according to the Detailed Description section with the following:~Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Mitoxantrone Hydrochloride, Gilteritinib
Experimental: High Risk
All eligible patients receive intervention according to the Detailed Description section with the following:~Venetoclax, Azacitidine, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Gilteritinib