A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma
In brief
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).
Key facts
- Study ID
- NCT02518113
- Run by
- Eli Lilly and Company
- People needed
- 36
- Starts
- 2015-10-01
- Expected to finish
- 2018-01-15
- Last updated by the study team
- 2019-09-11
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Have previously completed or withdrawn from this study or any other study investigating LY3039478 or other Notch inhibitors.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).
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
- University of Texas MD Anderson — Houston, Texas, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Lille, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Nantes, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Paris, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Pierre-Bénite, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Toulouse, France
- Johann Wolfgang Goethe-Universität Frankfurt — Frankfurt, Germany
- Universitätsklinikum Heidelberg — Heidelberg, Germany
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Ulm, Germany
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Haifa, Israel
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Jerusalem, Israel
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Ramat Gan, Israel
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Tel Aviv, Israel
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Milan, Italy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Naples, Italy
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Torino, Italy
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