Treatment of patients with Aggressive Lymphoma following Self Stem Cell Transplantatio
- Registration Number
- CTRI/2009/091/000566
- Lead Sponsor
- CureTech Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 68
1.Patient's age is 18 years or older, both genders.
2.Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
3.The lymphoma is chemosensitive.
4.The lymphoma did not progress since pre-transplant chemotherapy.
5.ECOG performance status 0-1.
1.Serious other illness.
2.Active autoimmune disease.
3.Type 1 diabetes.
4.Known immune deficiency.
5.Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
6.Active bacterial, fungal, or viral infection.
7.Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
8.Pregnant or nursing (positive pregnancy test).
9.Other concurrent clinical study or investigational therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died.Timepoint: Within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [Designated as safety issue: No] <br><br>
- Secondary Outcome Measures
Name Time Method 1.Evaluate the toxicity and safety of CT-011 in patients with DLBCL.<br>2.Evaluate the event free survival (events are defined as relapse, second malignancy or death) in patients treated with CT-011.<br>3.Evaluate the overall survival in patients treated with CT-011.<br>Timepoint: Within 18 months following autologous PBSCT.] [Designated as safety issue: Yes]