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

Completed

• Conditions: Stemcell transplatation; immune reconstitution; 10018849

• Registration Number: NL-OMON39524
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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 <= 10 mg/day, no cyclosporine, no mycophenolate mofetil)
• No active graft versus host disease

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Lymphocyte subset production rates and life spans during immune recovery<br /><br>following HSCT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>