A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL

A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

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• Have previously completed or withdrawn from this study or any other study investigating LY3039478 or other Notch inhibitors.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).