A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
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).
Inclusion Criteria:

 -  Have acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma
 (T-LBL).

 -  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.

 Exclusion Criteria:

 -  Have previously completed or withdrawn from this study or any other study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
 study medication.

 -  Have current or recent gastrointestinal disease with chronic or intermittent diarrhea,
 or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

 -  Have active leukemic involvement of the central nervous system (CNS).