Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00106925|
Recruitment Status : Recruiting
First Posted : April 1, 2005
Last Update Posted : October 1, 2019
|First Submitted Date||March 31, 2005|
|First Posted Date||April 1, 2005|
|Last Update Posted Date||October 1, 2019|
|Actual Study Start Date||April 22, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Assure consistency of care over time for transplant patients such that outcome data can be meaningfully accrued. [ Time Frame: Ongoing ]
monitor late effects of treatment and provide or recommend appropriate management
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00106925 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants|
|Official Title||Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants|
This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.
Patients between 10 and 80 years of age who received a donor stem cell transplant at the NIH Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
Participants are generally seen in the clinic every 12 months for some or all of the following procedures:
Disease relapse or progression, or transplant-related problems may be treated with standard medical, radiation, or surgical therapy, or patients may be offered experimental therapy.
While patients surviving more than three years from SCT have a high probability of being cured of their underlying disease, they are still at risk from several categories of complications which could remain lifelong risks including late recurrence (or continued persistence) of original disease, late effects from transplant related GVHD, immune dysfunction, or consequences from the chemotherapy and/or radiation given during transplant conditioning.
Since these complications are iatrogenic, the long term follow-up of SCT patients is the ethical responsibility of the transplant team. In addition, collecting data on late occurring complications allows for prospective evaluation of the long term consequences of surviving a particular transplant treatment approach (i.e. total body irradiation versus chemotherapy conditioning, T cell depleted versus T cell replete transplants).
This protocol is designed to allow for long term evaluation, data collection, and when needed standard medical care of patients (and when appropriate their stem cell donor) who have received allogeneic stem cell transplantation in NHLBI protocols. This may include patients with bone marrow failure states, cytopenias, hemoglobinopathies, metastatic solid tumors, or hematologic malignancies.
No investigational treatments will be administered on this protocol. Participation will not constitute a promise of long-term medical care at the NIH, nor will it provide for the evaluation and treatment of any non-transplant related medical problems. This protocol will provide access to NIH investigators experienced in the care of post transplant patients who can help transplant patients and their local physician manage post transplant complications. In return, data collected from subjects and their donors (when applicable) will provide NIH researchers valuable information and/or laboratory samples for the purposes of better understanding the long term consequences of stem cell transplantation and identifying areas in need of future research.
|Study Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Patients and donors (when applicable) will be co accrued to this protocol once they have survived a minimum of three years from date of transplant.@@@|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Patients surviving three years or more from date of first stem cell transplant who have been treated.
-With an experimental allogeneic stem cell transplant on a NHLBI HB protocol
-With a standard of care allogeneic stem cell transplant on the NHLBI standard of care protocol
-Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team
Age greater than or equal to 10 years old and age less than or equal to 80
For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
EXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS:
None, all patients meeting the inclusion criteria will be eligible
If appropriate clinical management of the recipient or ongoing laboratory research would indicate the need for additional stem cell collection or peripheral blood collection, a donor may also be accrued to this protocol providing they meet the following criteria:
No additional stem cells will be harvested for research purposes.
EXCLUSION CRITERIA-DONOR (ANY OF THE FOLLOWING):
|Ages||2 Years to 80 Years (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||050130
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 10, 2019|