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

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 - Leukemia reactive donor T cells

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37016

Enrollment

Registered

2012-09-19

Start date

2013-06-25

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymfomen leukemia

Interventions

Leukemia-reactive T cells are a cell therapy product that will be administered to patients with persistent or relapsed disease from 3 months after allo-SCT or DLI. The maximal number of T cells that

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Life expectation = II - Treatment with corticosteroids in an equivalent dose of >0.5 mg/kg prednisone - Pregnant or lactating women - Severe psychological disturbances

Design outcomes

Secondary

Measure	Time frame
- 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. - CR, PR and MR rate 12 weeks after last infusion of leukemia-reactive T cells. - Time to next leukemia/lymphoma treatment.	—

Primary

Measure	Time frame
- The number of acute GvHD, other serious adverse events and deaths within 12 weeks after last infusion of leukemia-reactive T cells. - The feasibility of generation of leukemia-reactive T cells for administration.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)