Phase 2 N=36 Randomized Treatment

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

T-cell Acute Lymphoblastic Leukemia · T-cell Lymphoblastic Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT02518113 ↗

Enrolled (actual)

Serious AEs

80.6%

Results posted

Feb 2019

Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 2; 2; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LY3039478 (Drug); Dexamethasone (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs)	0; 2; 2; 3	—
PRIMARY Recommended Dose of LY3039478 in Combination With Dexamethasone	75	—
PRIMARY Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)	1; 0; 0; 0	—
SECONDARY Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1	3480; 5000; 5870; 6330	—
SECONDARY Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8	3050; 4070; 4640; 8240	—
SECONDARY Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations	0; 0; 0; 0	—
SECONDARY Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR	—	—
SECONDARY Phase 2: Number of Participants Who Achieve PR	—	—
SECONDARY Phase 2: Duration of Remission (DoR)	—	—
SECONDARY Phase 2:Relapse Free Survival (RFS)	—	—
SECONDARY Phase 2: Event Free Survival (EFS)	—	—
SECONDARY Phase 2: Overall Survival (OS)	—	—
SECONDARY Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score	—	—

Summary

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).

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02518113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.