Bone Marrow TransplantationNCT00495300
Collection of Samples and Data for the National Marrow Donor Program Repository
An observational study of Bone Marrow Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Bone Marrow Transplantation
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2007to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive related donor transplants as well as matched unrelated donor (MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also include patients that have undergone a MUD transplant at another approved transplant center but need to receive additional blood products from the donor while at NIH after completing a transplant center transfer
Who may be able to join
- Patients (Recipient):
- Must be enrolled on an NIH IRB approved protocol which involves an HSC transplant or cellular therapy utilizing HSC from an unrelated donor affiliated with the NMDP.
- May include recipients who have received an NMDP facilitated HSC transplant at other institutions, provided the patient consents to and completes a Transplant Center transfer.
- Ability to comprehend and willing to sign the informed consent or have a parent/guardian consent if the donor is a minor; assent obtained from minors as appropriate.
- Allogeneic (related matched) recipients for TED level data submission only.
- Donors of related transplant.
Who cannot join
- The patient has received an HSC transplant or cellular therapy utilizing HSC from an unrelated donor facilitated by a registry other than NMDP.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Collection of Research Samples and/or Data for Repository From Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program
This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the Research Database Program and the Research Sample Repository.
Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study.
Read more
Participants in the NMDP Research Database program will have medical information about their disease and their transplant sent to the NMDP before and after the transplant and once a year for the rest of their life. The information will be used to help determine how well transplant recipients recover from their transplant, how recovery after a transplant can be improved, how access to transplant for different groups of patients can be improved and how well donors recover from collection procedures.
Participants in the NMDP Research Sample Repository program will have a small blood sample drawn from a vein in the arm just before they start taking medicines for the conditioning regimen to prepare them for the transplant. The blood samples will be used to look at ways to improve how patients are matched with their donors, to determine and evaluate the factors that affect transplant outcome, and to help develop methods to improve tissue matching between donors and recipients.
Read the detailed description
The National Institutes of Health (NIH) has entered into a Transplant Center Participation Agreement with the National Marrow Donor Program (NMDP). This agreement allows any NIH investigator with an NIH Institutional Review Board (IRB) approved protocol to secure hematopoietic stem cells (HSC) or cord blood units from the NMDP/CIBMTR registry for the purpose of transplanting patients who have no suitable matched related donors. As part of this agreement, the NMDP/CIBMTR Research Program requires that blood samples as well as baseline and outcome data (mainly demographic, quality of life, and clinical data) be collected and maintained in accordance with the NMDP/CIBMTR IRB approved protocols. The goal of the NMDP/CIBMTR Research Program is to improve the safety and effectiveness of unrelated donor HSC transplantation for both the donors and recipients, and to have a comprehensive source of data that can be used to study unrelated donor HSC transplantation. The NMDP/CIBMTR is the sole custodian of the data in the Research Database.
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) level data submission for Allogeneic recipient patients and their donors. This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive related donor transplants as well as matched unrelated donor (MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also include patients that have undergone a MUD transplant at another approved transplant center but need to receive additional blood products from the donor while at NIH after completing a transplant center transfer. As of 03/02/2020, all newly enrolled subjects will only have TED level data submission to NMDP.
- Conditions
- Bone Marrow Transplantation
- Keywords
- Data Collection, CIBMTR Samples, NMDP Repository, Hematopoietic Stem Cells, Bone Marrow Transplant Data Collection, Natural History, Samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) leve...
Ongoing
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study start31 Aug 2007
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Other
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Harry L Malech, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495300
- Sponsor's protocol ID
- 070183
- Other IDs
- 07-I-0183
- Status last verified
- Sep 2024
- First submitted
- 30 Jun 2007
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dufour C, Rondelli R, Locatelli F, Miano M, Di Girolamo G, Bacigalupo A, Messina C, Porta F, Balduzzi A, Iorio AP, Buket E, Madon E, Pession A, Dini G, Di Bartolomeo P; Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP); Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Stem cell transplantation from HLA-matched related donor for Fanconi's anaemia: a retrospective review of the multicentric Italian experience on behalf of AIEOP-GITMO. Br J Haematol. 2001 Mar;112(3):796-805. doi: 10.1046/j.1365-2141.2001.02572.x.
PubMed 11260086Chakraverty R, Peggs K, Chopra R, Milligan DW, Kottaridis PD, Verfuerth S, Geary J, Thuraisundaram D, Branson K, Chakrabarti S, Mahendra P, Craddock C, Parker A, Hunter A, Hale G, Waldmann H, Williams CD, Yong K, Linch DC, Goldstone AH, Mackinnon S. Limiting transplantation-related mortality following unrelated donor stem cell transplantation by using a nonmyeloablative conditioning regimen. Blood. 2002 Feb 1;99(3):1071-8. doi: 10.1182/blood.v99.3.1071.
PubMed 11807015Kolb HJ, Socie G, Duell T, Van Lint MT, Tichelli A, Apperley JF, Nekolla E, Ljungman P, Jacobsen N, van Weel M, Wick R, Weiss M, Prentice HG. Malignant neoplasms in long-term survivors of bone marrow transplantation. Late Effects Working Party of the European Cooperative Group for Blood and Marrow Transplantation and the European Late Effect Project Group. Ann Intern Med. 1999 Nov 16;131(10):738-44. doi: 10.7326/0003-4819-131-10-199911160-00004.
PubMed 10577296
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Collection of Research Samples and/or Data for Repository From Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program
- ClinicalTrials.gov ID
- NCT00495300
- Acronym / sponsor ID
- 070183
- Conditions
- Bone Marrow Transplantation
- Keywords
- Data Collection, CIBMTR Samples, NMDP Repository, Hematopoietic Stem Cells, Bone Marrow Transplant Data Collection, Natural History, Samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 31 Aug 2007 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP). The NMDP has two programs in which patients can participate: the Research Database Program and the Research Sample Repository.
Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study.
Participants in the NMDP Research Database program will have medical information about their disease and their transplant sent to the NMDP before and after the transplant and once a year for the rest of their life. The information will be used to help determine how well transplant recipients recover from their transplant, how recovery after a transplant can be improved, how access to transplant for different groups of patients can be improved and how well donors recover from collection procedures.
Participants in the NMDP Research Sample Repository program will have a small blood sample drawn from a vein in the arm just before they start taking medicines for the conditioning regimen to prepare them for the transplant. The blood samples will be used to look at ways to improve how patients are matched with their donors, to determine and evaluate the factors that affect transplant outcome, and to help develop methods to improve tissue matching between donors and recipients.
Detailed description
The National Institutes of Health (NIH) has entered into a Transplant Center Participation Agreement with the National Marrow Donor Program (NMDP). This agreement allows any NIH investigator with an NIH Institutional Review Board (IRB) approved protocol to secure hematopoietic stem cells (HSC) or cord blood units from the NMDP/CIBMTR registry for the purpose of transplanting patients who have no suitable matched related donors. As part of this agreement, the NMDP/CIBMTR Research Program requires that blood samples as well as baseline and outcome data (mainly demographic, quality of life, and clinical data) be collected and maintained in accordance with the NMDP/CIBMTR IRB approved protocols. The goal of the NMDP/CIBMTR Research Program is to improve the safety and effectiveness of unrelated donor HSC transplantation for both the donors and recipients, and to have a comprehensive source of data that can be used to study unrelated donor HSC transplantation. The NMDP/CIBMTR is the sole custodian of the data in the Research Database.
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) level data submission for Allogeneic recipient patients and their donors. This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive related donor transplants as well as matched unrelated donor (MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also include patients that have undergone a MUD transplant at another approved transplant center but need to receive additional blood products from the donor while at NIH after completing a transplant center transfer. As of 03/02/2020, all newly enrolled subjects will only have TED level data submission to NMDP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Related or Unrelated Hematopoietic Stem Cell Transplantation Recipients for the National Marrow Donor Program |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This protocol will include patients at the NIH that have enrolled in an NIH IRB approved protocol to receive related donor transplants as well as matched unrelated donor (MUD) HSC transplants or cord blood transplants facilitated by the NMDP/CIBMTR. It may also include patients that have undergone a MUD transplant at another approved transplant center but need to receive additional blood products from the donor while at NIH after completing a transplant center transfer
Key inclusion criteria (6 listed)
- Must be enrolled on an NIH IRB approved protocol which involves an HSC transplant or cellular therapy utilizing HSC from an unrelated donor affiliated with the NMDP.
- May include recipients who have received an NMDP facilitated HSC transplant at other institutions, provided the patient consents to and completes a Transplant Center transfer.
- Ability to comprehend and willing to sign the informed consent or have a parent/guardian consent if the donor is a minor; assent obtained from minors as appropriate.
- Allogeneic (related matched) recipients for TED level data submission only.
- Donors of related transplant.
Key exclusion criteria (1 listed)
- The patient has received an HSC transplant or cellular therapy utilizing HSC from an unrelated donor facilitated by a registry other than NMDP.
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
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) leve...
Time frame: Ongoing
Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 11260086Dufour C, Rondelli R, Locatelli F, Miano M, Di Girolamo G, Bacigalupo A, Messina C, Porta F, Balduzzi A, Iorio AP, Buket E, Madon E, Pession A, Dini G, Di Bartolomeo P; Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP); Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Stem cell transplantation from HLA-matched related donor for Fanconi's anaemia: a retrospective review of the multicentric Italian experience on behalf of AIEOP-GITMO. Br J Haematol. 2001 Mar;112(3):796-805. doi: 10.1046/j.1365-2141.2001.02572.x.
- Background: PubMed 11807015Chakraverty R, Peggs K, Chopra R, Milligan DW, Kottaridis PD, Verfuerth S, Geary J, Thuraisundaram D, Branson K, Chakrabarti S, Mahendra P, Craddock C, Parker A, Hunter A, Hale G, Waldmann H, Williams CD, Yong K, Linch DC, Goldstone AH, Mackinnon S. Limiting transplantation-related mortality following unrelated donor stem cell transplantation by using a nonmyeloablative conditioning regimen. Blood. 2002 Feb 1;99(3):1071-8. doi: 10.1182/blood.v99.3.1071.
- Background: PubMed 10577296Kolb HJ, Socie G, Duell T, Van Lint MT, Tichelli A, Apperley JF, Nekolla E, Ljungman P, Jacobsen N, van Weel M, Wick R, Weiss M, Prentice HG. Malignant neoplasms in long-term survivors of bone marrow transplantation. Late Effects Working Party of the European Cooperative Group for Blood and Marrow Transplantation and the European Late Effect Project Group. Ann Intern Med. 1999 Nov 16;131(10):738-44. doi: 10.7326/0003-4819-131-10-199911160-00004.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Harry L Malech, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary purpose of this protocol is to incorporate all the NMDP/CIBMTR requirements for securing data and blood samples on recipients whose transplant was facilitated by NMDP/CIBMTR here at NIH as well as TED (Transplant Essential Data) leve... (time frame: Ongoing). 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 NCT00495300, which also lists 3 linked publications.
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 4 Sep 2024.