EUCTR2018-002752-33-NL
Active, not recruiting
Phase 1
A phase I/II trial towards the safety and efficacy of preemptive vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells after Allogeneic Stem Cell Transplantation - mHag UTA2-1-loaded PD-L silenced DC vaccination after allo SCT
VU University Medical Center0 sites12 target enrollmentAugust 16, 2018
ConditionsMultiple 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: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma (MM), Chronic Lymphocytic Leukemia (CLL), Non hodgkin lymphoma (any grade), Acute myeloid leukemia (AML)
- Sponsor
- VU University Medical Center
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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