Trial record 1 of 1 for:    BMT CTN 1202
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Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMTCTN1202)

This study is currently recruiting participants.
Verified November 2013 by Medical College of Wisconsin
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01879072
First received: June 11, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The goal of this protocol is to establish a cohort of biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared biospecimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.


Condition
Recipients of Allogeneic Hematopoietic Stem Cell Transplantation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT Clinical Trials Network (CTN)#1202)

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Establish a cohort of biologic samples [ Time Frame: Two years from hematopoietic stem cell transplant ] [ Designated as safety issue: No ]
    To describe patterns of disease among patients undergoing allogeneic hematopoietic stem cell. The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared biospecimen resource for conducting future correlative studies.


Secondary Outcome Measures:
  • Acute Graft-versus-host disease (aGVHD) [ Time Frame: Day 100 ] [ Designated as safety issue: No ]
    To describe patterns of aGVHD using The date of onset, severity, target organ involvement, treatment, and evolution over time, including response to treatment of acute GVHD is the main outcome of interest for future testing of the collected samples.

  • Chronic Graft-versus-host disease (cGVHD) [ Time Frame: Two years post-transplant ] [ Designated as safety issue: No ]
    To describe patterns of cGVHD including the date of onset, severity, target organ involvement and evolution of chronic graft-versus-host disease.

  • Infections [ Time Frame: Day 100 ] [ Designated as safety issue: No ]
    To describe patterns of infections through day 100.

  • Relapse/Progression [ Time Frame: Two years ] [ Designated as safety issue: No ]
    To describe patterns of relapse/progression post-transplant.

  • Acute liver injury [ Time Frame: Day 100 ] [ Designated as safety issue: No ]
    To describe patterns of acute liver injury.

  • Lung Injury [ Time Frame: Two years ] [ Designated as safety issue: No ]
    To describe patterns of lung injury post-transplant.

  • Transplant-related mortality (TRM) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    To describe patterns of TRM post-transplant.


Biospecimen Retention:   Samples With DNA

10mL serum for Proteomic studies for all 1500 patients at the following time points: pre-transplant, days 7, 14, 21, 28, 42, 56 and 90.

Gene Expression studies will include the following:

  • PAXgene Lysates-source whole blood RNA (15 ml blood) for 240 patients collected on days 21 and 90.
  • CytoChex tube for Immunophenotyping (4-5 mL blood) collected on days 21 and 90.

Estimated Enrollment: 1500
Study Start Date: June 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Detailed Description:

The goal of this protocol is to establish a cohort of biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared biospecimen resource for conducting future allogeneic HCT correlative studies. This resource is designed to allow genomic, proteomic and transcriptional data to be integrated with high quality clinical phenotype and outcomes data to identify risk factors for development and severity of acute GVHD, chronic GVHD, organ toxicity, relapse, mortality, infection and other clinically significant complications occurring after allogeneic HCT.

To achieve this goal, patients and donors will be recruited and consent obtained at the time that they enroll on BMT CTN protocols where enrollment occurs at or before transplantation or prior to start of conditioning for patients enrolled on non-BMT CTN studies or treated as standard of care. Samples will be collected: (1) from patients and donors pre-transplant; and, (2) from patients post-transplant on a calendar schedule through the first 3 months post-HCT. For patients co-enrolled on BMT CTN studies, clinical data will be collected in the context of the primary transplant protocols. For patients not enrolled on BMT CTN protocols, clinical data on early post-transplant events will be collected using the same data collection forms and systems that are used on BMT CTN trials. Additional clinical data for both BMT CTN and non-BMT CTN patients will be available from data submitted to the Center for International Blood and Marrow Transplant Research (CIBMTR) using the CIBMTR Comprehensive Report Forms. This protocol also leverages ongoing pre-transplant donor-recipient sample collection performed by the CIBMTR and National Marrow Donor Program (NMDP). Success in establishing this shared resource will inspire future investigator initiated research proposals and will allow investigators to take advantage of National Institutes of Health (NIH) funding initiatives.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All U.S. Allogeneic Transplant Donors and Recipients weighing 20 or more kg may participate in the collection of samples.

Criteria

Inclusion Criteria:

  1. Recipients of first allogeneic hematopoietic cell transplants that are transplanted in U.S. centers that participate in the NMDP/CIBMTR's "Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries" and receive a cord blood graft or receive a bone marrow or peripheral blood graft from a related donor or from an unrelated donor in an NMDP-affiliated Donor Center or Registry participating in that same protocol.

    This transplant and donor center restriction is to allow linkage with pretransplant donor specimens collected under the NMDP/CIBMTR protocol. Current data indicate that >90% of donors approached under this protocol agree to provide samples

  2. Patients with any malignant or non-malignant hematologic disorder will be eligible for enrollment on this protocol. A subset of 240 sequential patients with acute leukemia in first or second remission will also provide research samples for gene expression studies.
  3. Children may participate in this study but must weigh at least 20 kilograms given the volume (100ml) and number of blood draws during this study. Subjects must weigh at least 30 kg to provide research samples for gene expression studies (additional 40 ml).
  4. All participants or parent/legal guardian must sign an informed consent for this study.

Because studies using this resource will require linking with clinical data collected by CIBMTR, all participants or parent/legal guardian must also consent to participate in "Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic Injuries".

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879072

Contacts
Contact: Linda Johnson 301-251-1161 ext 2834 ljohnson@emmes.com

Locations
United States, California
Stanford Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: David Miklos, MD, PhD    650-725-4626    dmiklos@stanford.edu   
United States, Florida
Nemours Childrens Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Anders Kolb, MD    302-651-5567    eakolb@nemours.org   
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48105-2967
Contact: John Levine, MD    734-247-2518    jelevine@med.umich.edu   
United States, Texas
University of Texas/MD Anderson CRC Recruiting
Houston, Texas, United States, 77030
Contact: Amin Alousi, MD    713-745-3055    aalousi@mdanderson.org   
Sponsors and Collaborators
Medical College of Wisconsin
Blood and Marrow Transplant Clinical Trials Network
Investigators
Study Director: Mary Horowitz, MD, MS Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
  More Information

Additional Information:
No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01879072     History of Changes
Other Study ID Numbers: BMTCTN1202, U10HL069294-11
Study First Received: June 11, 2013
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Medical College of Wisconsin:
Biomarkers
Hematopoietic stem cell transplant

ClinicalTrials.gov processed this record on April 17, 2014