Tumor Antigen loaded Dendritic Cell Vaccination for hematological malignancies after allogeneic transplantatio

Phase 1

• Conditions: Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), Non hodgkin lymphoma (any grade), Acute myeloid leukemia (AML); MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002752-33-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Patients with Multiple Myeloma (MM), or Chronic Lymphocytic Leukemia (CLL) or non hodgkin lymphoma (any grade) or acute myeloid leukemia AML
2. Recipient and donor have a mismatch in UTA2-1 mHag in the Graft versus Tumor (GvT) direction (recipient mHag positive, donor mHag negative).
4. Recipient and donor are positive for HLA-A*0201
5. Age 18-75 years
6. Absence of acute GvHD > grade 2 or extensive chronic GvHD
7. No treatment with immunosuppressive drugs such as prednisone, cyclosporine A and MMF at least 4 weeks prior to planned vaccination date.
8. WHO performance 0-2
9. Absence of severe cardiac hepatic, renal, or metabolic disease
10. Written informed consent
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified