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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02007811 |
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Date of registration:
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21/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination
B-cell therapy |
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Scientific title:
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Prospective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single Vaccination |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02007811 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Julia Winkler, MD |
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Address:
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Telephone:
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+49 9131 85 43112 |
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Email:
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julia.winkler@uk-erlangen.de |
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Affiliation:
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Name:
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Julia Winkler, MD |
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Address:
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Telephone:
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+49 9131 85 43112 |
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Email:
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julia.winkler@uk-erlangen.de |
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Affiliation:
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Name:
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Julia Winkler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Erlangen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. patients after allogeneic stem cell transplantation
2. Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
Exclusion Criteria:
1. Serostatus for EBV: R-/D+
2. Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV)
3. Chronic GvHD in middle- or high-risk group according to NIH staging
4. Rituximab administration after SCT
5. >10.000 EBV DNA copies/ml plasma
6. Recurrence of the haematological disorder needing therapeutic intervention
7. Secondary transplantation
8. SCT with transplant from a haploidentical donor
9. SCT with transplant from umbilical cord blood
10. CD34+-enriched transplant
11. in vitro T-cell depleted transplant
12. Pregnant or breast-feeding female
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aplastic Anemia
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Chronic Myeloid Leukemia
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Non Hodgkin's Lymphoma
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Acute Lymphoblastic Leukemia
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Hodgkin's Disease
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Acute Myeloid Leukemia
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Multiple Myeloma
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Myelodysplastic Syndrome
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Intervention(s)
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Biological: allogeneic donor derived B-lymphocytes
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Primary Outcome(s)
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Number of participants with adverse events (AEs), adverse reactions (ARs), serious adverse events (SAEs), serious adverse reactions (SARs) and suspected unexpected serious adverse reaction (SUSARs)
[Time Frame: for 120 days after administration of study medication]
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Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
[Time Frame: for 120 days after administration of study medication]
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Number of participants with EBV DNA copies/ml plasma higher than 50,000
[Time Frame: for 120 days after administration of study medication]
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Secondary Outcome(s)
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Number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.
[Time Frame: up to 120 days after administration of study medication]
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Change in the frequency of antibody-producing cells between dose groups
[Time Frame: before and 7 days after preponed single vaccination]
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Change of antigen-specific antibody concentration in serum/plasma between dose groups
[Time Frame: 1 day before and up to 120 days after administration of study medication]
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Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups
[Time Frame: 1 day before and up to 120 days after administration of study medication]
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Change of mean absolute number of B-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups.
[Time Frame: 1 day before and up to 120 days after administration of study medication]
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Secondary ID(s)
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UKER-BLZ-PH1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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