immune reconstitution recovery of the immune system
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (i) At least 18 years of age; (ii) Ability to understand and voluntarily sign the informed consent form for this study and ability to follow the study protocol; (iii) Treatment for hematological malignancy with an autologous stem cell transplantation for which (iv) the autologous transplant consists of non-T cell depleted stem cells, that are isolated from peripheral blood, and mobilized with G-CSF (and possibly Plexirafor); (v) sufficient kidney function, defined by serum creatinine level * 1.5 × upper limit of normal (ULN) and glomerular filtration rate > 30 mL/min (calculated by Cockcroft and Gault formula); (vi) sufficient liver function, defined by total serum bilirubin * 1.5 × ULN; (vii) serum aspartate transaminase (AST) and/or alanine transaminase (ALT) * 2.5 × ULN; (viii) women of child bearing potential must agree to use an adequate and medically accepted method of contraception (ix) patients starting the protocol 12-18 months post-transplantation should have a naive CD4+ T-cell count of at least 20/µl peripheral blood.
Exclusion criteria
Exclusion criteria: (i) Infection with human immunodeficiency virus (HIV); (ii) Active infection with hepatitis B or C or other active liver disease (iii) Other active uncontrolled infections, like malaria, infectious mononucleosis, sexually transmitted diseases; (iv) Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study; (v) Uncontrolled or significant cardiovascular disease, including: A myocardial infarction within 12 months; Uncontrolled angina within 6 months; Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4; (vi) Body weight below 50 kg (vii) Pregnancy or parent*s wish in the coming year; (viii) Excessive alcohol consumption (ix) Drug use (x) Extreme sensitivity to sea- and/or car sickness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameter of this study is the amount of deuterium (label) that the various leukocyte populations have incorporated in their DNA by cell division at a given time. For this purpose blood withdrawals are done both in the period during which participants drink 2H2O (uplabeling phase) and in the period after stopping with 2H2O intake (downlabeling phase). Data obtained during uplabeling and downlabeling phases can be interpreted by mathematical models that describe the dynamics of leukocyte populations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Deuterium enrichment in urine. This parameter will allow us to determine the level of deuterium in body water that was available to be incorporated into the various cell populations. This level can vary between individuals, dependent on how much normal (unlabeled) water was drunk by the participant. (ii) T cell excision circles and plasma levels of growth- survival- and inflammatory factors. (iii). The composition of the transplant. The presence of various leukocyte populations in the transplant can possibly influence the reconstitution rate of these cell populations. | — |
Countries
Netherlands
Outcome results
None listed