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. (see Contacts and Locations)
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

June 11, 2013
November 22, 2013
June 2013
July 2019   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01879072 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Prospective Cohort for the Evaluation of Biomarkers Following HCT
Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT Clinical Trials Network (CTN)#1202)

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Retention:   Samples With DNA
Description:

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.
Non-Probability Sample

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

Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
July 2019
July 2019   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Linda Johnson 301-251-1161 ext 2834 ljohnson@emmes.com
United States
 
NCT01879072
BMTCTN1202, U10HL069294-11
Yes
Medical College of Wisconsin
Medical College of Wisconsin
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Cancer Institute (NCI)
  • Blood and Marrow Transplant Clinical Trials Network
Study Director: Mary Horowitz, MD, MS Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Medical College of Wisconsin
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP