Transfer of multiantigen-specific T cells after allogeneic stem cell transplantation

Transfer of Streptamer selected multiantigen-specific T cells to prevent infections and relapse after allogeneic stem cell transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25777

Enrollment

Registered

2014-09-22

Start date

2014-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Patients with a haematological malignancy who are planned to undergo an allogeneic stem cell transplantation

Interventions

derived multi-antigen specific T cells

Eligibility

Inclusion criteria

Inclusion criteria: - Age 18-75 years - Planned T cell depleted allo-SCT for one of these diagnoses: o Acute Lymphoblastic Leukemia in CR after prephase and first induction and consolidation therapy and WBC < 30 x 109/l in B-ALL or < 100 x 109/l in T-ALL at initial diagnosis. ALL with t(9;22), t(4;11), complex karyotype or 11q23 abnormalities will be excluded. o Acute Myeloid Leukemia in CR excluding AML with: * Monosomal Karyotype * Abn3q26 * EVI1 overexpression o Multiple myeloma at least in stable PR (no treatment foreseen in first 6 months after allo-SCT) o Non high grade B-NHL (B-CLL, Mantle cell lymphoma, Follicular Lymphoma, MALT, LPL) at least in stable PR (no treatment foreseen in first 6 months after allo-SCT) o Myeloprolypherative disorder at least in stable PR (no treatment foreseen in first 6 months after allo-SCT), excluding CML blastic phase o Myelodysplastic syndrome at least in stable PR (no treatment foreseen in first 6 months after allo-SCT) - HLA type A*0201. - Written informed consent of the patient - Availability of a stem cell donor who meets the following inclusion criteria: o HLA type A*0201 o CMV and/ or EBV seropositivity o Written informed consent

Exclusion criteria

Exclusion criteria: - Disease specific treatment foreseen in the first 6 months after SCT - Life expectation < 6 months. - End stage irreversible multi-system organ failure (need for mechanical ventilation, hypotension for which admission to ICU, hepatic encephalopathy, coma). - Pregnant or lactating women or women with child bearing potential who are unwilling or not capable to use effective means of birth control. - Severe psychological disturbances.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of the transfer of multiantigen specific T cells by measuring the appearance or expansion (if antigenic specific donor derived cells are already present in the circulation of the patient at time of infusion) of antigen specific donor derived T cells during eight weeks after the infusion of donor derived multi antigen specific T cells.	—

Secondary

Measure	Time frame
To assess the feasibility and safety (toxicity) of the administration of donor derived multi antigen specific T cells early after T cell depleted allo-SCT.	—

Contacts

Public ContactC.J.M. Halkes

LUMC - C2-R140 Postbus 9600

+31 (0)71 5262261

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)