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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To investigate the feasibility and safety of administration of donor leukemia-reactive T cells.;Secondary Objective: - To evaluate the persistence of leukemia-reactive T cells after administration.<br>- To evaluate whether administration of leukemia-reactive T cells leads to complete remission (CR), partial remission (PR) or mixed response (MR) within 12 weeks after last infusion.<br>;Primary end point(s): - The number of acute GvHD, other serious adverse events and deaths within 12 weeks after last infusion of leukemia-reactive T cells.<br>- The feasibility of generation of leukemia-reactive T cells for administration.;Timepoint(s) of evaluation of this end point: - weekly until 12 weeks after last infusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - 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>- CR, PR and MR rate 12 weeks after last infusion of leukemia-reactive T cells. <br>- Time to next leukemia/lymphoma treatment.;Timepoint(s) of evaluation of this end point: - weekly until 12 weeks after last infusion

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