Acute Myeloid LeukemiaPhase 1/2B-cell therapyNCT02007811
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
A Phase 1/2 study testing allogeneic donor derived B-lymphocytes in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia
- What is being tested?
- allogeneic donor derived B-lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients after allogeneic stem cell transplantation
- Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Department 5, University Hospital Erlangen
Erlangen, 91054
Julia Winkler, MD, +49 9131 85 43112, julia.winkler@uk-erlangen.de
Andreas Mackensen, MD, +49 9131 85 35954, andreas.mackensen@uk-erlangen.de
About this study
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
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.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non Hodgkin's Lymphoma, Hodgkin's Disease, Myelodysplastic Syndrome
- Being tested
- allogeneic donor derived B-lymphocytes
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Non-Hodgkin, Hodgkin Disease, Myelodysplastic Syndromes, Multiple Myeloma, Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic donor derived B-lymphocytesBiological
CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses
| Study group | Role | What they receive |
|---|---|---|
| allogeneic donor derived B-lymphocytes | Experimental | Not described Receives: Biological: allogeneic donor derived B-lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with EBV DNA copies/ml plasma higher than 50,000
Measured: for 120 days after administration of study medication
Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
Measured: 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)
Measured: for 120 days after administration of study medication
Secondary outcomes (5)
Change in the frequency of antibody-producing cells between dose groups
Measured: 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.
Measured: 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
Measured: 1 day before and up to 120 days after administration of study medication
Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups
Measured: 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.
Measured: up to 120 days after administration of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Regensburg, Wuerzburg University Hospital, University Hospital, Essen, German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Julia Winkler, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007811
- Sponsor's protocol ID
- UKER-BLZ-PH1
- Acronym
- B-cell therapy
- Status last verified
- Mar 2014
- First submitted
- 21 Nov 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38467031
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02007811
- Acronym / sponsor ID
- B-cell therapy / UKER-BLZ-PH1
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non Hodgkin's Lymphoma, Hodgkin's Disease, Myelodysplastic Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- University Hospital Regensburg, Wuerzburg University Hospital, University Hospital, Essen, German Research Foundation
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allogeneic donor derived B-lymphocytes | Experimental | Biological: allogeneic donor derived B-lymphocytes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients after allogeneic stem cell transplantation
- Serostatus for EBV: R-/D- oder R+/D- oder R+/D+
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic donor derived B-lymphocytesCD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses | Biological | allogeneic donor derived B-lymphocytes |
Primary outcome
Number of participants with EBV DNA copies/ml plasma higher than 50,000
Time frame: 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
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
5 secondary outcomes
Change in the frequency of antibody-producing cells between dose groups
Time frame: 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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Derived from this study: PubMed 38467031Winkler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Winkler, MD principal investigator
University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing allogeneic donor derived B-lymphocytes in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Winkler, MD (+49 9131 85 43112, julia.winkler@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with EBV DNA copies/ml plasma higher than 50,000 (time frame: for 120 days after administration of study medication). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.