Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
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First Received Date ICMJE | March 31, 2005 | ||||||||
Last Updated Date | March 20, 2012 | ||||||||
Start Date ICMJE | March 2005 | ||||||||
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Change History | Complete list of historical versions of study NCT00106925 on ClinicalTrials.gov Archive Site | ||||||||
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Descriptive Information | |||||||||
Brief Title ICMJE | Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants | ||||||||
Official Title ICMJE | Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants | ||||||||
Brief Summary | 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. |
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Detailed Description | 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 hematologists 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. |
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Study Type ICMJE | Observational | ||||||||
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 99999999 | ||||||||
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Eligibility Criteria ICMJE |
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 Or -With a standard of care allogeneic stem cell transplant on the NHLBI standard of care protocol Or -As a special exemption to the above protocols 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 INCLUSION CRITERIA-DONOR: 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):
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Gender | Both | ||||||||
Ages | 10 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00106925 | ||||||||
Other Study ID Numbers ICMJE | 050130, 05-H-0130 | ||||||||
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Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
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Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | October 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |