None listed
Conditions
Interventions
CT-011 Type of group
CT-011 IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Sponsors
CureTech Ltd,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Patient´s age is 18 years or older, both genders. • Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage. • The lymphoma is chemosensitive. • The lymphoma did not progress since pre-transplant chemotherapy. • ECOG performance status 0-1.
Exclusion criteria
Exclusion criteria: • Serious other illness. • Active autoimmune disease. • Type 1 diabetes. • Known immune deficiency. • Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma. • Active bacterial, fungal, or viral infection. • Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia. • Pregnant or nursing (positive pregnancy test). • Other concurrent clinical study or investigational therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:PFS (progression-free survival ) will be determined at the eligible patient populations Measure:Progression-free Survival Timepoints:16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as the time elapsed from the first treatment to recurrence, death, second malignant disease or the last date on which the patient was disease free Measure:Event free survival Timepoints:During the study ; Outcome name:It is defined from the moment of the first treatment until death or the last known date on which the patient was alive Measure:Overall Survival Timepoints:within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). | — |
Countries
India, Israel, Peru, United States
Contacts
Public ContactPilar M Garcia
GENEXION S.A.C
Outcome results
None listed