Scientists collect blood samples to unlock secrets of immune rebuilding after transplant

NCT ID NCT02129543

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Recruiting now This study
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Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
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First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study collects blood samples from up to 700 people, including stem-cell transplant patients and their donors, to understand how the immune system recovers after transplant. Researchers will analyze immune cells and T cell subsets to learn about immune reconstitution and graft-versus-host disease. No treatments are being tested; the goal is to gather information for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could help doctors understand how to improve immune recovery after stem-cell transplants, potentially leading to better outcomes for patients.
What could go wrong
This is an observational study, not a treatment trial. It collects samples for research, so there is no direct benefit to participants. The findings may not lead to new therapies for many years.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2012

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* Arm A: All patients undergoing treatment for hematologic malignancy or bone marrow failure state. * Arm B: All cancer patients being treated with standard-of-care SCT will be studied. * Arm C: All patients being treated with adoptive T cell therapy. * Arm D: Patients without cancer for studies of immunophenotype and immunologic function as a control for cancer patients. Arms will include subjects ranging in age from late adolescence to approximately age 75; regardless of gender or ethnicity.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. This group of patients will include subjects ranging in age from late adolescence and adults of all ages, individuals of both sexes, and a wide variety of ethnic backgrounds. It is expected that up to 6 patients each month may be eligible for this arm of the study. 1. Age \> 18 years old 2. Enrollment for treatment with Anti-tumor T cells including either CARs, T-cell receptor (TCR)-transgenic, tumor-infiltrating lymphocytes (TILs), or Tregs, or donor lymphocyte infusion (DLI). 3. White Blood Cell count \> 100 k/microliter (uL). Patients will be screened based on their enrollment and planned treatment with T cells. Up to 1 month prior to conditioning chemotherapy baseline samples will be collected, which can be pre-infusion product or blood samples. Post T cell infusion samples will be collected and this study will include fresh, non-cryopreserved cerebrospinal fluid (CSF),and/or bone marrow (BM), and/or blood and/or serum obtained from patients treated with adoptively transferred T cells. Patient PHI information will be stored on a password protected computer and the database file will be password protected to maximize security of protected health information (PHI). This file will be accessible by the study investigators. * 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 Criteria: * Arms A, B, D: There are no exclusion criteria for this study. * Arm C: 1. Pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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