A study in T-ALL/T-LBL Patients

Phase 1

• Conditions: T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005024-10-SE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-07
• Study Completion: 2018-01-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Patients must have T-ALL or T-LBL. T-ALL is defined =25% of blasts in the bone marrow and expression of at least 2 of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and/or CD8. If the only T cell markers present are CD4 and CD7, the leukemia cells must also lack the myeloid markers CD33 and/or CD13. Patients with initial refractory disease should have received at least 2 multi-agent chemotherapy induction regimens. Patients in first or second relapse must have been refractory to at least 1 multi-agent chemotherapy reinduction regimen. They must have had at least 60 days between prior hematopoietic stem cell transplant and first dose of study drug, have adequate performance status and organ function, be =16 years old for the adult cohort (Phase 1, Part A) and 2 to <16 years old for the pediatric cohort (Phase 1, Part B), and have a life expectancy of 2 months.
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Patients may be excluded if they are currently enrolled in another ongoing clinical trial with investigational
products, have recently discontinued (within less than 2 weeks) prior anticancer therapy, have a serious concomitant illness, have an uncontrolled or active infection <7 days prior to administration of study drug, have current or recurrent (within 3 months) gastrointestinal disease, have conditions requiring chronic systemic glucocorticoid use, have active graft versus host disease, have active leukemic involvement of the central nervous system, or have a second primary or prior malignancy that would affect the interpretation of study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified