Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3578 (MHH) 1179/01 (PEI)
Study information
Scientific title
Acronym
HA1/HA2
Study hypothesis
Our 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
1. MHH Ethics committee received on 30th May 2007 (ref: 3578)
2. Paul-Ehrlich-Institute received on 12th February 2007 (ref: 1179/01)
Study design
Phase I/II experimental non-randomised, historical control trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Haematological malignacies/leukaemic relapse
Intervention
All 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 type
Drug
Phase
Phase I/II
Drug names
mHag HA1 or HA2 peptides
Primary outcome measure
Toxicity of immunisation
Secondary outcome measures
Prevention of relapse of leukaemia
Overall trial start date
01/11/2008
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant exclusion criteria
1. Acute or chronic graft-versus-host disease (GvHD) after allo-HSCT prior to immunisation
2. No informed consent
Recruitment start date
01/11/2008
Recruitment end date
31/10/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Hannover Medical School
Hannover
30625
Germany
Sponsor information
Organisation
Hannover Medical School (Medizinischen Hochschule Hannover) (Germany)
Sponsor details
Carl-Neuberg-Str. 1
Hannover
30625
Germany
info@mh-hannover.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) - grant via Integriertes Forschungs und Behandlungszentrum MHH (IFB)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list