A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 2 - Any |
Updated: | 2/8/2019 |
Start Date: | October 1, 2015 |
End Date: | January 15, 2018 |
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).
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- Have previously completed or withdrawn from this study or any other study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).
We found this trial at
8
sites
3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Murali Janakiram
Phone: 718-405-8510
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Daniel DeAngelo
Phone: 617-632-2645
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Detroit, Michigan 48201
Principal Investigator: Jay Yang
Phone: 313-576-8952
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Ibrahim Aldoss
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Houston, Texas 77030
Principal Investigator: Gautam Borthakur
Phone: 713-563-1586
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Jae Park
Phone: 212-639-2471
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Alexander Perl
Phone: 215-573-8478
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