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Immune Reconstitution in Stem Cell Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02129543
Recruitment Status : Recruiting
First Posted : May 2, 2014
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Miami

Brief 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.

Condition or disease Intervention/treatment
Cancer Procedure: Blood Draw

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Peripheral Blood Samples From Donors and Recipients of Blood and Marrow Transplants for Laboratory Research in Immune Reconstitution
Actual Study Start Date : August 15, 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
Arm A: Treatment for Malignancy/Failure

Patients undergoing treatment for hematologic malignancy or bone marrow failure state. Blood draws may be collected at certain time points during which the patient is being evaluated for a response to treatment. Collections may be acquired at the following timeframes:

  • At the time of diagnosis (prior to any treatment or therapy); and
  • Post each line of therapy
Procedure: Blood Draw
Whole blood samples will be collected from study subjects for immune cell and plasma analysis per protocol.

Arm B: Standard-of-Care SCT
All cancer patients being treated with standard-of-care SCT will be studied. Blood draws may be collected within 30 days pre-transplant; Post-transplant 14 days (± 2 days), 21 days (± 4 days), 30 days (+/- 7 business days); 60 days (+/- 21 business days); 100 days (+/- 30 business days); 6 months (+/- 30 business days); 1 year (+/- 30 business days) and annually (+/- 60 business days) thereafter.
Procedure: Blood Draw
Whole blood samples will be collected from study subjects for immune cell and plasma analysis per protocol.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood Samples Marrow Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Arm A: Will include subjects selected from all patients presenting to the clinical services of the Division of Hematology/Oncology, for treatment of hematologic disorders. This will include patients with a broad range of hematologic malignancies and bone marrow failure states.

Arm B: Will include subjects selected from all patients presenting to the clinical services of the Adult Cell Transplant Program as donors or recipients for SCT. All donors will have been cleared for clinical marrow or peripheral blood stem cell donation, and will be expected to be generally healthy.

Both arms will include subjects ranging in age from late adolescence to approximately age 75; individuals of both sexes; and a wide variety of ethnic backgrounds.

Criteria

Inclusion Criteria:

Arm A:

  • Patients presenting to the clinical services of the Division of Hematology/Oncology, for treatment of hematologic disorders.
  • Age ranging from late adolescence to approximately age 75.
  • Including patients with a broad range of hematologic malignancies and bone marrow failure states.

Arm B:

  • Stem Cell Transplant Donor
  • Stem Cell Transplant Recipient
  • Age range from late adolescence to age 75

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129543


Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Krishna Komaduri, MD    305-243-6356    kkomanduri@med.miami.edu   
Principal Investigator: Krishna Komaduri, MD         
Principal Investigator: Eric Wieder, PhD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Krishna V Komanduri, MD University of Miami

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Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT02129543     History of Changes
Other Study ID Numbers: 20080899
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Miami:
SCT
Stem Cell Transplantation
Stem Cell Transplant