A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
Phase: Phase 1/Phase 2
DFCI Protocol ID: 15-226
The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Children's Hospital Boston, Massachusetts General Hospital
Daniel DeAngelo, MD,
Dana-Farber Cancer Institute
Andrew Place, MD, PhD,
Dana Farber Cancer Institute
Amir Fathi, M.D.,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, email@example.com
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- Have acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma
- T-ALL or T-LBL participants with relapsed/refractory disease.
- Have had at least 60 days between prior hematopoietic stem cell transplantation (SCT)
and first dose of study drug.
- Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)
scale for adults.
- Lansky score >50% for participants <16 years old.
- Have adequate organ function.
- Are at least:
- adult Phase 1 Part A and Phase 2: ≥16 years old at the time of screening
- pediatric Phase 1 Part B: 2 to <16 years old
- Men and women with reproductive potential: Must agree to use a reliable method of
birth control during the study and for 3 months following the last dose of study
drug(s) or country requirements, whichever is longer.
- Females with childbearing potential: Have had a negative serum pregnancy test ≤7 days
before the first dose of study drug and also must not be breastfeeding.
- Are able to swallow capsules and tablets.
- Have previously completed or withdrawn from this study or any other study
investigating LY3039478 or other Notch inhibitors.
- Have evidence of uncontrolled, active infection <7 days prior to administration of
- Have current or recent gastrointestinal disease with chronic or intermittent
diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel
- Have active leukemic involvement of the central nervous system (CNS).