Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantatio

Not Applicable

• Conditions: -C851 B-cell lymphoma, unspecified; B-cell lymphoma, unspecified; C851

• Registration Number: PER-097-09
• Lead Sponsor: CureTech Ltd,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:PFS (progression-free survival ) will be determined at the eligible patient populations<br><br>Measure:Progression-free Survival<br>Timepoints:16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).<br>

Secondary Outcome Measures

Name	Time	Method
<br>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<br>Measure:Event free survival<br>Timepoints:During the study<br>;<br>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<br>Measure:Overall Survival<br>Timepoints:within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).<br>