Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00106925 : Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
PhaseN/A
AgesMin: 10 Years Max: 80 Years
Eligibility
- INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:

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:

- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00106925      |      Link to official Clinicaltrials.gov listing
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