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
- Conditions
- lymfomenleukemialymphoma10024324
- Registration Number
- NL-OMON37016
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
- allo-SCT patient with a sibling or unrelated stem cell donor matched for at least HLA-A, -B, -C, and -DR alleles (8/8).;
- Age 18-75 years;
- WHO performance score 0-2;
- Persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement at least 3 months after allo-SCT or DLI;
- Possibility to collect > 5 x 10^7 mononuclear cells containing > 25% malignant B cells from blood or bone marrow of patient, or availability of patient malignant B cells cryopreserved at a GMP-facility;
- Donor willing to donate PBMC, or cryopreserved donor PBMC available in an amount of >=1 x 10^9 MNC/ total;
- Written informed consent
- Life expectation <3 months
- End stage irreversible multi-system organ failure
- Acute GvHD overall grade >= II
- Treatment with corticosteroids in an equivalent dose of >0.5 mg/kg prednisone
- Pregnant or lactating women
- Severe psychological disturbances
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- The number of acute GvHD, other serious adverse events and deaths within 12<br /><br>weeks after last infusion of leukemia-reactive T cells.<br /><br>- The feasibility of generation of leukemia-reactive T cells for<br /><br>administration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Increase in number of leukemia-reactive T cells in blood and/or bone marrow<br /><br>at different time points after infusion of leukemia-reactive T cells.<br /><br>- CR, PR and MR rate 12 weeks after last infusion of leukemia-reactive T cells.<br /><br>- Time to next leukemia/lymphoma treatment.</p><br>