Mixed chimerism after allogeneic stem cell transplantation Injury, Occupational Diseases, Poisoning Mixed chimerism
Conditions
Interventions
Week 0: The study starts when DLI is given in an eligible patient
Week 8: Bone marrow investigation for chimerism and/or disease evaluation. GVHD evaluation and measurement of HA-1 specific T cells. I
Sponsors
Leiden University Medical Centre (LUMC) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Toxicity (phase 1), monitored every two weeks until end of study 2. Appearance of HA-1 specific CD8+ lymphocytes, monitored at weeks 6 and 8 and from 10 - 26 weeks after DLI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone marrow chimerism, monitored at weeks 8, 12, 15, 19 and 26 2. Disease activity, monitored at weeks 8, 12, 15, 19 and 26 | — |
Countries
Netherlands
Outcome results
None listed