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
NCT ID: NCT02007811
Last Updated: 2014-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2013-11-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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allogeneic donor derived B-lymphocytes
allogeneic donor derived B-lymphocytes
CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses
Interventions
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allogeneic donor derived B-lymphocytes
CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses
Eligibility Criteria
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Inclusion Criteria
2. Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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University Hospital Regensburg
OTHER
Wuerzburg University Hospital
OTHER
University Hospital, Essen
OTHER
German Research Foundation
OTHER
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Julia Winkler, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Erlangen
Locations
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Medical Department 5, University Hospital Erlangen
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Winkler J, Tittlbach H, Schneider A, Vasova I, Strobel J, Herold S, Maas S, Spriewald BM, Repp R, Kordelas L, Mach M, Wolff D, Edinger M, Mackensen A, Winkler TH. Adoptive transfer of donor B lymphocytes: a phase 1/2a study for patients after allogeneic stem cell transplantation. Blood Adv. 2024 May 28;8(10):2373-2383. doi: 10.1182/bloodadvances.2023012305.
Other Identifiers
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UKER-BLZ-PH1
Identifier Type: -
Identifier Source: org_study_id
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