Clinical Trial: Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides
Brief Summary: Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment with their own genetically modified T cells. Treatment evaluation consists of assessment of safety and preliminary evidence of response.
Detailed Summary:
Sponsor: University of Cologne
Current Primary Outcome:
- Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
- Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
Original Primary Outcome: Same as current
Current Secondary Outcome: Preliminary evidence of response to treatment
- Complete Response (CR): Disappearance of treated lesion.
- Partial Response (PR): At least 30% decrease in the sum of two diameters compared to the initiatal diameters of the treated lesion.
- Progressive Disease (PD): At least 20% increase in the sum of two diameters of treated lesions.
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of two diameters while on study.
Original Secondary Outcome: Same as current
Information By: University of Cologne
Dates:
Date Received: July 11, 2012
Date Started:
Date Completion:
Last Updated: July 17, 2012
Last Verified: July 2012
