Immune Reconstitution in Stem Cell Transplant Recipients

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT02129543
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Blood Draw — PROCEDURE
    Whole blood samples will be collected from study subjects for immune cell and plasma analysis per protocol.

Study Details

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.

Key Dates

Start date
Aug 15, 2012
Status verified
Dec 2025
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Arm B: Standard-of-Care SCT Group
    Participants in this group will be cancer participants being treated with standard of care stem cell therapy
  • Arm: Arm C: Adoptive T Cell Therapy Group
    Participants in this group will be participants being treated with adoptive T cell therapy.
  • Arm: Arm D: Control Group
    Participants without cancer for studies of immunophenotype and immunologic function.

Primary Outcome Measure

Rate of Immune Reconstitution in Study Participants [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Jay Spiegel, MD
[email protected]
305-243-0372
Jay Spiegel, MD (PRINCIPAL_INVESTIGATOR)
Eric Wieder, PhD (PRINCIPAL_INVESTIGATOR)
Cara Benjamin, PhD (PRINCIPAL_INVESTIGATOR)
Jonathan Schatz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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