- Newly diagnosed ALL
- 1 year of age or younger at the time of diagnosis
- Has not had any — or has had limited — prior therapy
- Does not have mature B-cell ALL, acute myeloid leukemia (AML) or Down syndrome
This study will enroll participants up to 1 year of age who have acute lymphoblastic leukemia (ALL). Infants in this study have leukemia cells that may have a mutation in a gene called MLL (mixed lineage leukemia), which is a common mutation in infants with ALL. Infants and children with this type of leukemia tend to have a high risk of relapse, and most do not respond well to current leukemia therapies.
This study tests a new treatment approach that adds two new anti-cancer drugs called bortezomib and vorinostat to the standard chemotherapy used to treat ALL. Bortezomib and vorinostat have been approved by the US Food and Drug Administration to treat other cancers in adults, but they have not been approved for treating children with leukemia.
- To find out if adding bortezomib and vorinostat to commonly used chemotherapy regimen will be safe and effective in treating infants with newly diagnosed ALL.
- To gather information about the side effects of the combination therapy in infants.
- To learn more about the biology and genetics of infant ALL by studying blood and bone marrow samples in research laboratories.
- To find better ways to measure minimal residual disease (MRD) in infants with ALL.
- Participant is less than or equal to 365 days of age at the time of diagnosis.
- Participant has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with less than or equal to 25% blasts in the bone marrow (M3), with or without extramedullary disease.
- Note: Participants with T-cell ALL are eligible. Participants with bi-lineage or bi-phenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid.
- Participant has no prior therapy or participant has had limited prior therapy, including glucocorticoids for one week or less, one dose of vincristine, and one dose of intrathecal chemotherapy.
- Note: Other circumstances must be cleared by the PI or co-PI.
- Participant has had prior therapy, other than the therapy specified above and in Section 3.1.3 of the protocol.
- Participant has mature B-cell ALL or acute myeloid leukemia (AML).
- Participant has Down syndrome.
- Participant’s legal guardian or representative is unable or unwilling to give written informed consent following IRB, NCI, FDA and OHRP guidelines.
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children’s Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
About this clinical trial
This study will enroll infants up to 1 year of age who have acute lymphoblastic leukemia (ALL). ALL is a cancer of the white blood cells. Most children over age 1 who have ALL are cured. This is not true for infants with ALL, as less than half are cured.
Some doctors have used special treatments for infants with ALL. Other doctors have treated infants with the same treatments used in older children. Infants in this study have leukemia cells that may have a mutation in a gene called MLL (mixed lineage leukemia). This mutation is common in infants with ALL. Infants and children with this type of leukemia tend to have a high risk of relapse (leukemia returns). Most do not respond well to current treatments. In this study, doctors will use a new approach. They will add two new anti-cancer drugs called bortezomib and vorinostat to the standard ALL treatment.
Purpose of this clinical trial
The purpose of this study is to test the good and bad effects of the anti-cancer drugs bortezomib and vorinostat when given with chemotherapy commonly used to treat ALL in children. The drugs have been approved by the US Food and Drug Administration to treat other cancers in adults, but they have not been approved for treating children with leukemia. Doctors will gather details about the therapy’s side effects. They hope to learn more about the biology and genetics of infant ALL by studying blood and bone marrow samples. Doctors will also find better ways to measure minimal residual disease (MRD) in infants with ALL.
TINI Quick View Sponsor St. Jude Children's Research Hospital and collaborating sites in and outside the U.S. ClinicalTrials.gov identifier NCT02553460 Trial start date October 2015 Estimated enrollment 50 Study type Interventional Study phase Phase 2 Condition Cancer Ages Up to 1 year old Principal investigator Tanja A. Gruber, MD, PhD Study site St. Jude Children's Research Hospital
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