Dendritic cells vaccination after allogeneic stem cell transplantatio

Phase 1

• Conditions: Patients with aggressive hematological malignancies treated with allogeneic stem cell transplantation; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002879-34-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-24
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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, HLA-A24, HLA-B7 and/or HLA-B44
• 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified