Back to resultsOpen-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)
Primary Purpose
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
allogeneic donor derived B-lymphocytes
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- patients after allogeneic stem cell transplantation
- Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
Exclusion Criteria:
- Serostatus for EBV: R-/D+
- Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV)
- Chronic GvHD in middle- or high-risk group according to NIH staging
- Rituximab administration after SCT
- >10.000 EBV DNA copies/ml plasma
- Recurrence of the haematological disorder needing therapeutic intervention
- Secondary transplantation
- SCT with transplant from a haploidentical donor
- SCT with transplant from umbilical cord blood
- CD34+-enriched transplant
- in vitro T-cell depleted transplant
- Pregnant or breast-feeding female
Sites / Locations
- Medical Department 5, University Hospital ErlangenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
allogeneic donor derived B-lymphocytes
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with EBV DNA copies/ml plasma higher than 50,000
Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
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)
Secondary Outcome Measures
Change in the frequency of antibody-producing cells between dose groups
Change of mean absolute number of B-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups.
Change of antigen-specific antibody concentration in serum/plasma between dose groups
Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups
Number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.
Full Information
NCT ID
NCT02007811
First Posted
November 21, 2013
Last Updated
March 24, 2014
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
University Hospital Regensburg, Wuerzburg University Hospital, University Hospital, Essen, German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02007811
Brief Title
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
Acronym
B-cell therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
University Hospital Regensburg, Wuerzburg University Hospital, University Hospital, Essen, German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non Hodgkin's Lymphoma, Hodgkin's Disease, Myelodysplastic Syndrome, Multiple Myeloma, Aplastic Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
allogeneic donor derived B-lymphocytes
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
allogeneic donor derived B-lymphocytes
Intervention Description
CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses
Primary Outcome Measure Information:
Title
Number of participants with EBV DNA copies/ml plasma higher than 50,000
Time Frame
for 120 days after administration of study medication
Title
Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
Time Frame
for 120 days after administration of study medication
Title
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
Secondary Outcome Measure Information:
Title
Change in the frequency of antibody-producing cells between dose groups
Time Frame
before and 7 days after preponed single vaccination
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients after allogeneic stem cell transplantation
Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
Exclusion Criteria:
Serostatus for EBV: R-/D+
Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV)
Chronic GvHD in middle- or high-risk group according to NIH staging
Rituximab administration after SCT
>10.000 EBV DNA copies/ml plasma
Recurrence of the haematological disorder needing therapeutic intervention
Secondary transplantation
SCT with transplant from a haploidentical donor
SCT with transplant from umbilical cord blood
CD34+-enriched transplant
in vitro T-cell depleted transplant
Pregnant or breast-feeding female
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Winkler, MD
Phone
+49 9131 85 43112
Email
julia.winkler@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Wolf Rösler, MD
Phone
+49 9131 85 43115
Email
wolf.roesler@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Winkler, MD
Organizational Affiliation
University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Department 5, University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Winkler, MD
Phone
+49 9131 85 43112
Email
julia.winkler@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Andreas Mackensen, MD
Phone
+49 9131 85 35954
Email
andreas.mackensen@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Julia Winkler, MD
12. IPD Sharing Statement
Learn more about this trial
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
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