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|NCT00106925 : Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants|
|Ages||Min: 10 Years Max: 80 Years|
- INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:
Patients surviving three years or more from date of first stem cell transplant who have
-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
-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
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:
- HLA 5/6 or 6/6 matched family donor
- Weight greater than or equal to 18 kg
- Age greater than or equal to 2 or less than or equal to 80 years old
- Age greater than or equal to 18 years of age (if participating only as a donor of
peripheral blood cells for laboratory research studies).
- 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.
No additional stem cells will be harvested for research purposes.
EXCLUSION CRITERIA-DONOR (ANY OF THE FOLLOWING):
- Pregnant or actively breastfeeding
- Donor unfit to receive filgrastim and undergo apheresis. (Uncontrolled hypertension,
history of congestive heart failure or unstable angina, thrombocytopenia)
- HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the
risk-benefit ratio is considered acceptable by the patient and investigator.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00106925
| Link to official Clinicaltrials.gov listing