CMLNCT00511537
Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
An observational study of CML and ALL, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. Read more about this study
- Who is it for?
- Ages 16 to 54 years
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Jun 2009
- 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 16 to 54 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with Hematopoeietic Disorders
Who may be able to join
- Age >15 and <55
- Adequate renal function with serum creatinine <2.0 mg/dl
- Pulmonary diffusing capacity>50% of predicted
- Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
- Total bilirubin must be <2.5 mg/dl.
- Alkaline phosphatase and AST must be less than three times the upper limit of normal
Show all 9Show fewer
- Negative serology for the human immunodeficiency virus
- Available HLA-matched donor
- Signed informed consent
Who cannot join
- No fully or single-antigen-mismatched sibling donor is available to donate stem cells
- No active liver disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.
Read the detailed description
This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.
- Conditions
- CML, ALL, AML, Myelodysplasia, Lymphoma, Myeloproliferative Disorders
- Keywords
- AML, ALL, CML, Lymphoma, Myelodysplasia, Unrelated stem cell transplantation, Hematopoietic disorders
- Medical subject headings
- Anemia, Refractory, with Excess of Blasts, Lymphoma, Myeloproliferative Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJan 1999
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMLStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas G. Martin, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511537
- Sponsor's protocol ID
- UC-9907-CC99251
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2007
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
- ClinicalTrials.gov ID
- NCT00511537
- Acronym / sponsor ID
- UC-9907-CC99251
- Conditions
- CML, ALL, AML, Myelodysplasia, Lymphoma, Myeloproliferative Disorders
- Keywords
- AML, ALL, CML, Lymphoma, Myelodysplasia, Unrelated stem cell transplantation, Hematopoietic disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Aug 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 study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.
Detailed description
This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Hematopoeietic Disorders
Key inclusion criteria (9 listed)
- Age >15 and <55
- Adequate renal function with serum creatinine <2.0 mg/dl
- Pulmonary diffusing capacity>50% of predicted
- Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
- Total bilirubin must be <2.5 mg/dl.
Key exclusion criteria (2 listed)
- No fully or single-antigen-mismatched sibling donor is available to donate stem cells
- No active liver disease.
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
Not reported in the source record.
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 2 Aug 2013.
Related trials for CML
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
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.
Thomas G. Martin, M.D. principal investigator
University of California, San Francisco
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 CML and ALL, run by University of California, San Francisco 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 9 inclusion and 2 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 2 Aug 2013. 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.
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 2 Aug 2013.