Condition category
Cancer
Date applied
16/10/2008
Date assigned
20/11/2008
Last edited
20/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Arnold Ganser

ORCID ID

Contact details

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

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 measures

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

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

http://www.mh-hannover.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes