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A phase I/II *minor histocompatibility antigen (mHag)-based Dendritic cell (DC) vaccination trial after allogeneic Stem Cell Transplantation (allo-SCT) to improve the safety and efficacy of donor lymphocyte infusions.

A phase I/II *minor histocompatibility antigen (mHag)-based Dendritic cell (DC) vaccination trial after allogeneic Stem Cell Transplantation (allo-SCT) to improve the safety and efficacy of donor lymphocyte infusions. - mHag donor DC vaccination in haematological malignancy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37500
Enrollment
30
Registered
2012-06-22
Start date
2014-05-23
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

bone marrow and lymphatic organs cancers of the blood hematological malignacy

Interventions

Suitable patients will be treated with a combined infusion of donor DC*s and DLI which are loaded with relevant mHags. Patients with minimal 1 relevant mismatch in the Graft versus Tumor direction a

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Patient with a measurable persistent disease after preceding DLI given for persistent or relapsed malignancy after allo-SCT. Reinduction chemotherapy in case of rapidly progressive disease (e.g. in AML) is allowed. 2. Recipient and donor with at least one relevant mismatch in mHags HA-1, HA-2, ACC1, ACC2, PANE1, LRH-1, CD19L or HB-1 in the Graft versus Tumor (GvT) direction (recipient mHag positive, donor mHag negative). 3. Recipient and donor positive for the relevant HLA, presenting the mismatched mHag(s). 4. Expression of the mismatched mHag in the lineage from which the malignancy has arisen. 5. Age 18-70 years 6. Absence of acute GvHD > grade 1 or extensive chronic GvHD 7. No prior or concomitant treatment for 8 weeks with immunosuppressive drugs such as prednisone, cyclosporine A and MMF. 8. WHO performance 0-2 (see appendix 1) 9. Absence of severe cardiac hepatic, renal, or metabolic disease 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. WHO performance 3-4 2. Presence of severe cardiac hepatic, renal, metabolic disease 3. Rapidly progressive disease, despite reinduction therapy 4. Life expectancy

Design outcomes

Primary

MeasureTime frame
Primary endpoints are the evaluation of safety and efficacy, the occurance of GvHD and the induction of a positive response to the combined DLI and DC treatment

Secondary

MeasureTime frame
The immune effects of the combined modality including the induction of specific mHag responses

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)