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.

Phase 2

Completed

• Conditions: bone marrow and lymphatic organs; cancers of the blood; hematological malignacy; 10035227

• Registration Number: NL-OMON37500
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are the evaluation of safety and efficacy, the occurance of<br /><br>GvHD and the induction of a positive response to the combined DLI and DC<br /><br>treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The immune effects of the combined modality including the induction of specific<br /><br>mHag responses </p><br>