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 |
| Protocol serial number | 3578 (MHH) 1179/01 (PEI) |
| Sponsor | Hannover Medical School (Medizinischen Hochschule Hannover) (Germany) |
| Funder | German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) - grant via Integriertes Forschungs und Behandlungszentrum MHH (IFB) |
- 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
Scientific
Hannover Medical School
Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation
OE6860
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I/II experimental non-randomised, historical control trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | HA1/HA2 |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | mHag HA1 or HA2 peptides |
| Primary outcome measure(s) |
Toxicity of immunisation |
| Key secondary outcome measure(s) |
Prevention of relapse of leukaemia |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 25 |
| Key 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 |
| Key exclusion criteria | 1. Acute or chronic graft-versus-host disease (GvHD) after allo-HSCT prior to immunisation 2. No informed consent |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Hannover Medical School
Hannover
30625
Germany
30625
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
