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)

March 24, 2014 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Medical Department 5, University Hospital Erlangen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julia Winkler, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: allogeneic donor derived B-lymphocytes
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with EBV DNA copies/ml plasma higher than 50,000
Time Frame: for 120 days after administration of study medication
for 120 days after administration of study medication
Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
Time Frame: for 120 days after administration of study medication
for 120 days after administration of study medication
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
for 120 days after administration of study medication

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the frequency of antibody-producing cells between dose groups
Time Frame: before and 7 days after preponed single vaccination
before and 7 days after preponed single vaccination
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
1 day before and up to 120 days after administration of study medication
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
1 day before and up to 120 days after administration of study medication
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
1 day before and up to 120 days after administration of study medication
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
up to 120 days after administration of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

German Research Foundation
University Hospital, Essen
Wuerzburg University Hospital
University Hospital Regensburg

Investigators

  • Principal Investigator: Julia Winkler, MD, University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKER-BLZ-PH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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