Vaccination with human minor H antigen (HA-1) peptide after allogeneic stem cell transplantatio

Completed

Conditions: Mixed chimerism after allogeneic stem cell transplantation
Injury, Occupational Diseases, Poisoning
Mixed chimerism

Registration Number: ISRCTN80896844

Lead Sponsor: eiden University Medical Centre (LUMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Patients with acute myeloid leukaemia (AML), myelodysplasia (MDS), acute lymphoblastic leukaemia (ALL), chronic myeloid leukaemia (CML) in accelerated phase or blastic transformation before transplantation, chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or aggressive lymphoma, who underwent allo-SCT (both myeloablative and non-myeloablative) followed by DLI for persistent mixed chimerism or smoldering disease
2. Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative
3. World Health Organization (WHO) performance status of 0, 1 or 2
4. Female patients of childbearing potential must be neither pregnant nor breastfeeding and must agree to use effective contraception (birth control pills, condoms, approved implant, or intra-uterine device [IUD]) during the course of this trial and for at least three months after the last injection
5. Mixed chimerism or persisting disease 8 weeks after DLI
6. Male and female, aged 18 years and older

Exclusion Criteria

1. Life expectation of less than 3 months
2. Psychological disturbances
3. Severely limited life expectation due to diseases other than the malignancy
4. Human immunodeficiency virus (HIV) positivity
5. Persistent treatment with high-dose corticosteroids (greater than 20 mg prednisone a day), chemotherapy or other immunosuppressive drugs
6. Rapidly progressive disease
7. GVHD grade 3 or 4
8. HA-1 specific immune response (defined by greater than 0.2% of total CD8+ cells in first six patients and defined by greater than 1.0% of total CD8+ cells in patients 4 - 24 if no toxicity greater than grade II in first three patients). No important increase in percentage HA-1 specific CD8+ cells between 6 and 8 weeks after DLI (defined as a doubling of this percentage resulting in a percentage of greater than 0.2%).