Administration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement.
Recruiting
- Conditions
- relapsed mature B cell neoplasmrecidief rijpcellig B cel neoplasma
- Registration Number
- NL-OMON28584
- Lead Sponsor
- eiden University Medical Center (LUMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Allo-SCT patient with a sibling or unrelated stem cell donor matched for at least HLA-A, -B, -C, and –DR alleles (8/8);
2. Age 18-75 years;
Exclusion Criteria
1. Life expectation < 3 months;
2. End stage irreversible multi-system organ failure;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The number of acute GvHD, other serious adverse events and deaths within 12 weeks after last infusion of leukemia-reactive T cells;<br /><br>2. The feasibility of generation of leukemia-reactive T cells for administration.
- Secondary Outcome Measures
Name Time Method 1. Increase in number of leukemia-reactive T cells in blood and/or bone marrow at different time points after infusion of leukemia-reactive T cells;<br /><br>2. CR, PR and MR rate 12 weeks after last infusion of leukemia-reactive T cells;<br /><br>3. Time to next leukemia/lymphoma treatment.