Hematologic NeoplasmsLTDFUNCT01362179
National Marrow Donor Program Long-Term Donor Follow-Up
An observational study of Hematologic Neoplasms, run by Center for International Blood and Marrow Transplant Research at 29 sites in 2 countries.
Trial summary
This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematologic Neoplasms
- How many people
- 21,974 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Oct 2010to 15 Oct 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 10,000 unstimulated BM donors and 20,000 filgrastim-mobilized PBSC donors
Who may be able to join
- Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
- Unrelated donor who received at least one injection of filgrastim or more, but did not donate filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
- Donation was managed by a U.S. NMDP donor center.
- Signed informed consent for participation in this long-term donor follow-up study. Concurrent enrollment on other studies is permitted.
Who cannot join
- Unrelated donor who donated filgrastim-mobilized bone marrow.
- Donation was managed by a non-U.S. donor center.
- Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Community Blood Center, Inc.
Appleton, Wisconsin, 54914-9106
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6013
New York Blood Center
Brooklyn, New York, 11201
National Marrow Donor Program Southeast District
Charlotte, North Carolina, 28269
Blood Assurance, Inc.
Chattanooga, Tennessee, 37403-1207
National Marrow Donor Program Northcentral District
Cleveland, Ohio, 44131
Baylor Research Institute
Dallas, Texas, 75246-2029
Colorado Marrow Donor Program
Denver, Colorado, 80230-6918
City of Hope
Duarte, California, 91010-3012
Cook Children's
El Paso, Texas, 79913
OneBlood
Fort Lauderdale, Florida, 33309
LifeSource
Glenview, Illinois, 60025-2498
Michigan Blood
Grand Rapids, Michigan, 49503
Hawaii Bone Marrow Donor Registry
Honolulu, Hawaii, 96817-1651
Gulf Coast Regional Blood Center
Houston, Texas, 77054-1802
Indiana Blood Center
Indianapolis, Indiana, 46208-4437
Cooperative Appalachian Marrow Program Medic Regional Blood Center
Knoxville, Tennessee, 37601
National Marrow Donor Program Southcentral District, Heart of America
Leawood, Kansas, 66206
DKMS Americas
New York, New York, 10016
National Marrow Donor Program Northern California & Northwest District
Oakland, California, 94612
Oklahoma Blood Institute
Oklahoma City, Oklahoma, 73104-3251
The HLA Registry
Oradell, New Jersey, 07649
National Marrow Donor Program Northeast District
Philadelphia, Pennsylvania, 19123-3594
Rhode Island Blood Center
Providence, Rhode Island, 02908-4811
Rock River Valley Blood Center
Rockford, Illinois, 61107
South Texas Blood and Tissue Center
San Antonio, Texas, 78201-2023
National Marrow Donor Program Southern California & Southwest District
Santa Ana, California, 92705
Scott & White Clinic
Temple, Texas, 76508-0001
Puerto Rico1 site
National Marrow Donor Program at Puerto Rico
Guaynabo, PR, 00968-2710
About this study
Official title: Incidence of Hematologic and Non-Hematologic Malignancies, Thrombotic Events, and Autoimmune Disorders in Unrelated Normal Donors Undergoing Bone Marrow Harvest Versus Peripheral Blood Stem Cell Mobilization With Recombinant Human Granulocyte Colony-Stimulating Factor (rHuG-CSF)
This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors.
Read the detailed description
This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors. Donors will undergo biennial surveys until study completion. Cases of targeted disorders will be reviewed by the medical monitors to confirm the veracity of the report.
- Conditions
- Hematologic Neoplasms
- Keywords
- malignant myeloid hematologic disorders, filgrastim, long term incidence, donors who received and in those who did not receive filgrastim.
- Medical subject headings
- Hematologic Neoplasms
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 |
|---|---|---|
| unstimulated BM donors | Observational (non-interventional) study. | |
| filgrastim-mobilized PBSC donors | Observational (non-interventional) study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malignant myeloid hematologic disorders
To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.
Measured: Post HSCT donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startOct 2010
- Primary completion30 Sep 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 21,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- John P Miller, MD, PhD, Principal investigator, National Marrow Donor Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362179
- Sponsor's protocol ID
- LTDFU
- Acronym
- LTDFU
- Status last verified
- Mar 2020
- First submitted
- 26 May 2011
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hematologic and Non-Hematologic Malignancies, Thrombotic Events, and Autoimmune Disorders in Unrelated Normal Donors Undergoing Bone Marrow Harvest Versus Peripheral Blood Stem Cell Mobilization With Recombinant Human Granulocyte Colony-Stimulating Factor (rHuG-CSF)
- ClinicalTrials.gov ID
- NCT01362179
- Acronym / sponsor ID
- LTDFU / LTDFU
- Conditions
- Hematologic Neoplasms
- Keywords
- malignant myeloid hematologic disorders, filgrastim, long term incidence, donors who received and in those who did not receive filgrastim.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,974 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- National Marrow Donor Program
- Study start
- Oct 2010
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 30 May 2011 (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 is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors.
Detailed description
This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized PBSC donors. Donors will undergo biennial surveys until study completion. Cases of targeted disorders will be reviewed by the medical monitors to confirm the veracity of the report.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unstimulated BM donors | – | –Observational (non-interventional) study. |
| filgrastim-mobilized PBSC donors | – | –Observational (non-interventional) study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 10,000 unstimulated BM donors and 20,000 filgrastim-mobilized PBSC donors
Key inclusion criteria (4 listed)
- Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
- Unrelated donor who received at least one injection of filgrastim or more, but did not donate filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
- Donation was managed by a U.S. NMDP donor center.
- Signed informed consent for participation in this long-term donor follow-up study. Concurrent enrollment on other studies is permitted.
Key exclusion criteria (3 listed)
- Unrelated donor who donated filgrastim-mobilized bone marrow.
- Donation was managed by a non-U.S. donor center.
- Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.
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
Incidence of malignant myeloid hematologic disorders
Time frame: Post HSCT donation
To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.
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 20 Oct 2020.
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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.
John P Miller, MD, PhD principal investigator
National Marrow Donor Program
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Neoplasms, run by Center for International Blood and Marrow Transplant Research at 29 sites in 2 countries.
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 4 inclusion and 3 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. 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?
Incidence of malignant myeloid hematologic disorders (time frame: Post HSCT donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2020.