A phase I/II study of vaccination against minor histocompatibility antigens HA1 or HA2 after allogeneic stem cell transplantation for advanced haematological malignancies

ISRCTN ISRCTN11974092
DOI https://doi.org/10.1186/ISRCTN11974092
Secondary identifying numbers 3578 (MHH) 1179/01 (PEI)
Submission date
16/10/2008
Registration date
20/11/2008
Last edited
20/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Arnold Ganser
Scientific

Hannover Medical School
Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation
OE6860
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Study information

Study designPhase I/II experimental non-randomised, historical control trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymHA1/HA2
Study objectivesOur aim is to demonstrate the feasibility, safety and efficacy of vaccination with mHag HA1 or HA2 peptides on day +120 after HLA-identical allogeneic haematopoietic stem cell transplantation (HSCT) with mHag disparate donor recipient pairs. We reason that vaccination with recipient mHag will boost the graft-versus-leukaemia effect of HSCT and thus lower the incidence of relapse in patients with high risk haematological malignancies.
Ethics approval(s)1. MHH Ethics committee received on 30th May 2007 (ref: 3578)
2. Paul-Ehrlich-Institute received on 12th February 2007 (ref: 1179/01)
Health condition(s) or problem(s) studiedHaematological malignacies/leukaemic relapse
InterventionAll patients will receive immunisation with mHA1 or 2 peptides in HLA-A2 patients with donor-recipient disparities in mHA1 or 2.

Historical controls will be used for evaluation of a benefit for patients with HA1 disparities and advanced haematological malignancies.

Duration of intervention per patient/subject: 18 months after vaccination.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I/II
Drug / device / biological / vaccine name(s)mHag HA1 or HA2 peptides
Primary outcome measureToxicity of immunisation
Secondary outcome measuresPrevention of relapse of leukaemia
Overall study start date01/11/2008
Completion date31/10/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants25
Key inclusion criteria1. Advanced (high risk) leukaemia, after allogeneic haematopoietic stem cell transplantation (HSCT)
2. Disparity in HA1 or HA2 between donor and recipient
3. Informed consent
4. Aged 18 years or older, either sex
Key exclusion criteria1. Acute or chronic graft-versus-host disease (GvHD) after allo-HSCT prior to immunisation
2. No informed consent
Date of first enrolment01/11/2008
Date of final enrolment31/10/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Hannover Medical School
Hannover
30625
Germany

Sponsor information

Hannover Medical School (Medizinischen Hochschule Hannover) (Germany)
Hospital/treatment centre

Carl-Neuberg-Str. 1
Hannover
30625
Germany

Email info@mh-hannover.de
Website http://www.mh-hannover.de/
ROR logo "ROR" https://ror.org/00f2yqf98

Funders

Funder type

Government

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) - grant via Integriertes Forschungs und Behandlungszentrum MHH (IFB)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan