CancerNCT02129543
Immune Reconstitution in Stem Cell Transplant Recipients
An observational study of Cancer, run by University of Miami at 1 site in United States.
Trial summary
This specimen collection lab protocol will allow the investigators to prospectively study immune reconstitution in patients being treated for hematologic disorders and immune factors affecting graft versus host disease in stem-cell transplant (SCT) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2012to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 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.
Who may be able to join
- 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.
- Age > 18 years old
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- 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).
- 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.
Who cannot join
- Arms A, B, D: There are no exclusion criteria for this study.
- Arm C:
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Jay Spiegel, MD, 305-243-0372, spiegelj@med.miami.edu
Jay Spiegel, MD
About this study
Official title: Collection of Peripheral Blood Samples From Donors and Recipients of Blood and Marrow Transplants for Laboratory Research in Immune Reconstitution
This specimen collection lab protocol will allow the investigators to prospectively study immune reconstitution in patients being treated for hematologic disorders and immune factors affecting graft versus host disease in stem-cell transplant (SCT) patients.
- Conditions
- Cancer
- Being tested
- Blood Draw
- Keywords
- SCT, Stem Cell Transplantation, Stem Cell Transplant
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Whole blood samples will be collected from study subjects for immune cell and plasma analysis per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Treatment for Malignancy/Failure Group | Participants in this group will be those who are undergoing treatment for hematologic malignancy or bone marrow failure state. Receives: Procedure: Blood Draw | |
| Arm B: Standard-of-Care SCT Group | Participants in this group will be cancer participants being treated with standard of care stem cell therapy Receives: Procedure: Blood Draw | |
| Arm C: Adoptive T Cell Therapy Group | Participants in this group will be participants being treated with adoptive T cell therapy. Receives: Procedure: Blood Draw | |
| Arm D: Control Group | Participants without cancer for studies of immunophenotype and immunologic function. Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Immune Reconstitution in Study Participants
The rate of immune reconstitution in study participants treated for hematologic disorders and malignancies including SCT donors and recipients.
Measured: 1 year
Secondary outcomes (2)
T cell subsets derived from samples for participants receiving stem cell therapy
Identification of the T cell subsets derived from samples from participants receiving stem cell therapy.
Measured: 1 year
Immune status of responders and non-responders to CAR-T therapy
Immune status as determined via the examination of genomic profiles of responders vs non-responders to CAR-T therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start15 Aug 2012
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Spiegel, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129543
- Sponsor's protocol ID
- 20080899
- Other IDs
- NCI-2019-08554
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2014
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Peripheral Blood Samples From Donors and Recipients of Blood and Marrow Transplants for Laboratory Research in Immune Reconstitution
- ClinicalTrials.gov ID
- NCT02129543
- Acronym / sponsor ID
- 20080899
- Conditions
- Cancer
- Keywords
- SCT, Stem Cell Transplantation, Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Aug 2012 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This specimen collection lab protocol will allow the investigators to prospectively study immune reconstitution in patients being treated for hematologic disorders and immune factors affecting graft versus host disease in stem-cell transplant (SCT) patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Treatment for Malignancy/Failure Group | – | Procedure: Blood DrawParticipants in this group will be those who are undergoing treatment for hematologic malignancy or bone marrow failure state. |
| Arm B: Standard-of-Care SCT Group | – | Procedure: Blood DrawParticipants in this group will be cancer participants being treated with standard of care stem cell therapy |
| Arm C: Adoptive T Cell Therapy Group | – | Procedure: Blood DrawParticipants in this group will be participants being treated with adoptive T cell therapy. |
| Arm D: Control Group | – | Procedure: Blood DrawParticipants without cancer for studies of immunophenotype and immunologic function. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- Arms A, B, D: There are no exclusion criteria for this study.
- Arm C:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawWhole blood samples will be collected from study subjects for immune cell and plasma analysis per protocol. | Procedure or surgery | Arm A: Treatment for Malignancy/Failure Group, Arm B: Standard-of-Care SCT Group, Arm C: Adoptive T Cell Therapy Group, Arm D: Control Group |
Primary outcome
Rate of Immune Reconstitution in Study Participants
Time frame: 1 year
The rate of immune reconstitution in study participants treated for hematologic disorders and malignancies including SCT donors and recipients.
2 secondary outcomes
T cell subsets derived from samples for participants receiving stem cell therapy
Time frame: 1 year
Immune status of responders and non-responders to CAR-T therapy
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Spiegel, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Spiegel, MD (305-243-0372, spiegelj@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Immune Reconstitution in Study Participants (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.