Observational Study of Immune Reconstitution After Stem Cell Transplant
This study is looking at how the immune system recovers (immune reconstitution) in people who have had a stem cell transplant for blood cancers (hematologic disorders). Researchers will collect whole blood samples from participants to analyze immune cells and plasma. The main goal is to understand the rate at which the immune system recovers over one year. You may be able to join if you are between 18 and 75 years old and are receiving treatment for a blood disorder or have had a stem cell transplant. This is an observational study, meaning researchers will be watching and collecting information without giving new treatments.
- Study design
- This is an observational study with a planned enrollment of 700 participants. It is not specified if there are different treatment groups or if it is blinded.
- What's involved
- You would have whole blood samples collected for immune cell and plasma analysis, as outlined in the study protocol.
- Compensation
- Not stated in the trial record.
- Follow-up
- The rate of immune reconstitution will be measured at 1 year.
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NCT02129543
Immune Reconstitution in Stem Cell Transplant Recipients
Recruiting
Not specifiedAges 18–75ObservationalUniversity of MiamiInvestigator-initiated
~700 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:Blood Draw
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Immune Reconstitution in Study Participants
Measured over 1 year
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Jay Spiegel, MD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Arm A: The study population will include subjects selected from all patients presenting to the clinical services of the Division of Hematology or Transplantation and Cellular Therapy. As a result, this group will consist of a diverse assortment including subjects ranging in age from late adolescence to approximately age 75; individuals of both sexes; and a wide variety of ethnic backgrounds. This will include patients with a broad range of hematologic malignancies and bone marrow failure states. We will attempt to study a broad range of patients and not exclude subjects on the basis of sex, ethnicity, age, or disease status in order to derive a more complete understanding of variables important in immune reconstitution. It is expected that up to 10 patients each month may be eligible for this study. Up to 200 patients may be enrolled in this arm.
Arm B: The study population will include subjects selected from all patients presenting to the clinical services of the Transplantation and Cellular Therapy Program as donors or recipients for SCT or cellular therapy. As a result, this group will consist of a diverse assortment including subjects ranging in age from late adolescence to approximately age 75; individuals of both sexes; and a wide variety of ethnic backgrounds. All donors will have been cleared for clinical marrow or peripheral blood stem cell donation, and will be expected to be generally healthy.
Recipients will include patients with a broad range of malignancies and will be among those selected as clinically fit to undergo SCT. Pregnant women will not be included among recipients, but may be present among donor subjects unless contraindicated for clinical purposes. For purposes of optimizing specific laboratory assays, subjects may be chosen on the basis of known serologic status (e.g., those with a history of positive immunoglobulin G (lgG) indicating a history of infection with cytomegalovirus (CMV), for assays of CMV-specific T cell function). While it may not be possible to study each patient presenting as a SCT recipient or donor, we will attempt to study a broad range of patients and not exclude subjects on the basis of sex, ethnicity, age, or disease status in order to derive a more complete understanding of variables important in immune reconstitution following SCT. It is expected that up to 6 patients each month may be eligible for this study.
Arm C: The study population will include patients undergoing Chimeric antigen receptor (CAR) T therapy.
Arm D: The goal of this aim is to study groups of subjects to understand immune function in individuals without cancer, as a reference group for studies of patients with cancer (including those receiving hematopoietic cell transplants and immune effector cell therapies). We also expect that these studies will have value independently to derive an understanding of protective human immunity in patients without cancer, but in relation to pathogen-specific immunity. This includes immunity to chronic viral infections (e.g., the herpesviruses that include Cytomegalovirus (CMV), Epstein-Barr virus (EBV),human herpesvirus-6 (HHV-6) and varicella zoster virus (VZV)), to epidemic and pandemic viruses (e.g., seasonal influenza, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) and to other pathogens (e.g., measles) that are important targets of antiviral immunity.
Exclusion
Arm C:
What this trial measures
- Rate of Immune Reconstitution in Study Participants1 year
The rate of immune reconstitution in study participants treated for hematologic disorders and malignancies including SCT donors and recipients.