Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a phase I study)

Completed

Conditions: blood cell cancer
hematological malignancies
10027656

Registration Number: NL-OMON40014

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL, MM or malignant NHL, who underwent HLA-matched allo-SCT
* Patients positive for HLA-A2 and/or HLA-B7
* Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor
* Patients >18 and <65 years of age
* WHO performance 0-2
* Witnessed written informed consent

Exclusion Criteria

* Life expectancy < 3 months;* Severe neurological or psychiatric disease;* Progressive disease needing cytoreductive therapy;* HIV positivity;* Patients with acute GVHD grade 3 or 4;* Patients with extensive chronic GVHD;* Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment;* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease;* Severe pulmonary dysfunction (CTCAE III-IV);* Severe renal dysfunction (serum creatinine > 3 times normal level);* Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level);* Patients with known allergy to shell fish

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are to evaluate the safety, toxicity, development<br /><br>of GVHD and the immunological response by appearance of MiHA-specific CD8+ T<br /><br>cells following vaccination with monocyte-derived donor DC electroporated with<br /><br>mRNA encoding hematopoietic-restricted MiHA in patients who had undergone<br /><br>allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are to evaluate the clinical effect of MiHA-DC<br /><br>vaccination in case of detectable minimal residual disease and mixed chimerism.</p><br>