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

Status: Recruiting
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).

Conducting Institutions:

Dana-Farber Cancer Institute, Brigham and Women's Hospital, Children's Hospital Boston, Massachusetts General Hospital

Overall PI:

Daniel DeAngelo, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Andrew Place, MD, PhD, Dana Farber Cancer Institute

Amir Fathi, M.D., Massachusetts General Hospital

Contacts:

Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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  -  Have previously completed or withdrawn from this study or any other study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

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