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In vivo measurement of lymphocyte kinetics during immune reconstitution after hematopoietic stem cell transplantation using [6,6-2H2]-glucose labeling

In vivo measurement of lymphocyte kinetics during immune reconstitution after hematopoietic stem cell transplantation using [6,6-2H2]-glucose labeling - SILAS: Stable Isotope Labeling After Stemcelltransplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39524
Enrollment
25
Registered
2012-01-03
Start date
2012-08-27
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stemcell transplatation

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients who underwent autologous or allogeneic stem cell transplantation because of a hematological malignancy • Complete remission before HSCT • Age 18-65 years • WHO performance score 0-2 • Outpatient clinic patients Inclusion criteria - specific for autologous HSCT • Indication for HSCT: relapsed non-Hodgkin*s lymphoma • Remission-induction chemotherapy schedule including Rituximab • Conditioning regimen: BEAM chemotherapy (BCNU (Carmustine), Ara-C (cytarabine), etoposide (VP16), Melphalan) Inclusion criteria - specific for allogeneic HSCT • Indication for HSCT: acute myeloid leukemia (AML) • Type of transplant: non-mismatched sibling donor (n=5) and matched unrelated donor (MUD; n=5), non-T cell depleted peripheral blood derived stem cell transplant • Conditioning regimen (myeloablative): cyclophosphamide and total body irradiation for sibling donors; cyclophosphamide, total body irradiation and anti-thymocyte globulin for unrelated donors • No or minimal immune suppression (prednisone

Exclusion criteria

Exclusion criteria: • Acute graft-versus-host disease or infectious complications necessitating hospital admission; • Active hematological malignancy; • HIV, hepatitis B, hepatitis C infection • Pre-treatment with immunomodulatory or lymphocyte depleting drugs such as lenalidomide, fludarabine or alemtuzumab • AML relapse and/or previous autologous or allogeneic HSCT • Significant renal, hepatic or cardiac dysfunction • Diabetes mellitus type 1, DM type 2 • Alcohol and/or drug abuse • Unwilling or not capable to use effective means of birthcontrol

Design outcomes

Primary

MeasureTime frame
Lymphocyte subset production rates and life spans during immune recovery following HSCT

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)