Vaccination with HA-1 peptide in patients showing minimal residual disease or mixed chimerism after allogeneic stem cell transplantation and donor lymphocyte infusion - HA-1 peptide vaccination after stem cell transplantatio

Conditions: Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent allo SCT (both myeloablative and non-myeloablative) followed by DLI for persistent mixed chimerism or smoldering disease. Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative. Absence of HA-1 specific immune response 8 weeks after allogeneic stem cell transplantation

Registration Number: EUCTR2007-004334-16-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent allo SCT (both myeloablative and non-myeloablative) followed by DLI for persistent mixed chimerism or smoldering disease
Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative.
WHO performance status of 0, 1 or 2 (see appendix)
No pregnancy, not breast feeding
Willing to use of effective contraception during the course of this trial and for at least three months after the last injection.
Life expectation of > 3 months
No severe psychological disturbances

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

HIV positivity

Graft versus host disease grade 3 or 4

At eight weeks after DLI a HA-1 specific immune response (defined by >0.2% of total CD8+ cells) in first three patients

Rapidly progressive disease needing cytoreductive treatment

At eight weeks after DLI a HA-1 specific immune response (defined by >1.0% of total CD8+ cells) in patients 4-24 if no toxicity >grade II in first three patients

Between six and eight weeks after DLI a doubling of percentage HA-1 specific CD8+ cells to a final percentage >0.2%

Necessity of persistent treatment with high-dose corticosteroids (> 20 mg prednisone a day), chemotherapy or immunosuppressive drugs.