ANBL1531 for High-Risk Neuroblastoma

What is the Purpose of this Study?

We are doing this study to find out if we can improve the treatment for patients with high-risk neuroblastoma by adding the study drug 131I-MIBG (131I-metaiodobenzylguanidine) or the study drug crizotinib to the standard treatment.
What is the Condition Being Studied?
Newly Diagnosed High-Risk Neuroblastoma

Who Can Participate in this Study?

Children and Adults with Neuroblastoma who:

- Are 1 year old and less than 30 years old

- Are able to tolerate peripheral blood stem cell collection

Age Group
Both
Participating Institutions

What is Involved?

If you choose to be in this study, you will:

- Be randomized (like drawing numbers out of a hat) to get either:

-- Group 1: Standard of care treatment

-- Group 2: Study drug 131I-MIBG and standard of care treatment

-- Group 3: Study drug 131I-MIBG and one stem cell transplant and standard of care chemotherapy

-- Group 4: Standard of care treatment

-- Group 5: Study drug Crizotinib plus standard of care treatment

- Have a scan and have tissue taken from your tumor sent for a test to see if it contains a specific gene

- Have standard treatment called induction therapy

Study Details

Full Title
ANBL1531: A Phase 3 Study of 131 I-Metaiodobenzylguanidine (131 I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL)
Principal Investigator

Contacts
Protocol Number
IRB:
PRO00100226

NCT:
NCT03126916
ClinicalTrials.gov
View on ClinicalTrials.gov