Allogeneic Hematopoietic Stem Cell TransplantationNCT01879072
Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation, run by Medical College of Wisconsin at 42 sites in United States.
Trial summary
The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- How many people
- 1,860 participants
- Where
- 42 sitesUnited States
- Study dates
- Jun 2013to Sep 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All U.S. Allogeneic Transplant Donors and Recipients weighing 20 or more kg may participate in the collection of samples.
Who may be able to join
- 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
- 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.
- 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).
- 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".
Who cannot join
- N/A
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48105-2967
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
BMT at Northside Hospital
Atlanta, Georgia, 30342
Johns Hopkins
Baltimore, Maryland, 21231
DFCI/Brigham & Women's
Boston, Massachusetts, 02115
Roswell Park
Buffalo, New York, 14263
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, 43210
Children's Medical Center of Dallas
Dallas, Texas, 75235
City of Hope National Medical Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27705
Cook Children's Hospital
Fort Worth, Texas, 76104
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Baylor College of Medicine/The Methodist Hospital
Houston, Texas, 77030
University of Texas/MD Anderson CRC
Houston, Texas, 77030
University of Kansas Hospital
Kansas City, Kansas, 66160
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Children's Hospital at Oakland
Oakland, California, 94609
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Utah BMT/Primary Children's Medical Center
Salt Lake City, Utah, 84132
Texas Transplant Institute
San Antonio, Texas, 78229
University of CA, SF
San Francisco, California, 94143
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110
Washington University/St. Louis Children's Hospital
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
Stanford Hospitals and Clinics
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)
The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.
Read the 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 bio specimen 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.
- Keywords
- Biomarkers, Hematopoietic stem cell transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Providing Biologic Samples
The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.
Measured: Two years from hematopoietic stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- 1,860 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Mary Horowitz, MD, MS, Study director, Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879072
- Sponsor's protocol ID
- BMTCTN1202
- Other IDs
- U10HL069294-11, 5U24CA076518
- Status last verified
- Dec 2022
- First submitted
- 11 Jun 2013
- Last updated
- 9 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Findings will be published in a manuscript.
Publications
Bhasin-Chhabra B, Wang T, Levine JE, Shenoy S, Perales MA, Bashey A, Raff H, Saber W. Soluble urokinase plasminogen activator receptor and acute kidney injury in hematopoietic cell transplantation. Blood Adv. 2025 Dec 23;9(24):6394-6401. doi: 10.1182/bloodadvances.2025016655.
PubMed 40991367
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Cohort for the Evaluation of Biomarkers Predicting Risk of Complications and Mortality Following Allogeneic HCT (BMT CTN #1202)
- ClinicalTrials.gov ID
- NCT01879072
- Acronym / sponsor ID
- BMTCTN1202
- Keywords
- Biomarkers, Hematopoietic stem cell transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,860 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program
- Study start
- Jun 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Posted 29 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this protocol is to establish a cohort of at least 1500 biologic samples collected prospectively from patients treated in BMT CTN centers that will be a shared bio specimen resource for conducting future allogeneic hematopoietic stem cell transplantation (HCT) correlative studies.
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 bio specimen 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All U.S. Allogeneic Transplant Donors and Recipients weighing 20 or more kg may participate in the collection of samples.
Key inclusion criteria (6 listed)
- 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
- 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.
- 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).
- All participants or parent/legal guardian must sign an informed consent for this study.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Providing Biologic Samples
Time frame: Two years from hematopoietic stem cell transplant
The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40991367Bhasin-Chhabra B, Wang T, Levine JE, Shenoy S, Perales MA, Bashey A, Raff H, Saber W. Soluble urokinase plasminogen activator receptor and acute kidney injury in hematopoietic cell transplantation. Blood Adv. 2025 Dec 23;9(24):6394-6401. doi: 10.1182/bloodadvances.2025016655.
- Individual participant dataSharing planned: Yes. Findings will be published in a manuscript.
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Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
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RecruitingObservational study
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
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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. This study is not recruiting at the moment.
Mary Horowitz, MD, MS study director
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation, run by Medical College of Wisconsin at 42 sites 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites 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?
Yes. Results are posted in the registry (first posted 29 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Providing Biologic Samples (time frame: Two years from hematopoietic stem cell transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879072, which also lists 1 linked publication.
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 9 Dec 2022.