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Improving Allogeneic Stem Cell Transplantation
Untitled Document
Name of the Trial
Phase I Pilot Study of T-Cell-Depleted Allogeneic Stem Cell Transplantation
after Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation
Conditioning in Patients with Hematologic Malignancies (NCI-04-C-0116). See
the protocol summary.
Principal Investigator
Dr. Michael R. Bishop, with Dr. Robert Dean (Protocol Chair), NCI Center for
Cancer Research.
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Dr. Michael Bishop
Principal Investigator |
Why Is This Trial Important?
Some patients with hematologic malignancies (blood or bone-marrow cancers)
can be cured with allogeneic stem cell transplantation (ASCT). After preparative
chemotherapy, doctors introduce donor stem cells into the patient's bloodstream,
where they migrate to bone marrow and help restore the immune system. White
blood cells are critical immune-system components. Cytotoxic T cells can kill
cells they recognize as foreign, including cancer cells. When this process occurs
after ASCT, doctors call it the graft-versus-malignancy effect.
Stem cell donors are usually genetically similar (matched) siblings or unrelated
volunteers, but over half of patients lack a matched donor. To address this
problem, researchers have studied the use of partially matched (haploidentical)
donors. However, ASCT from haploidentical donors often causes serious complications,
including graft-versus-host-disease (GVHD), which occurs when donor T cells
attack normal tissues.
In this study, researchers are testing whether a modified transplantation regimen
may reduce complications while preserving the benefits of haploidentical ASCT.
The researchers will use reduced doses of transplant chemotherapy to decrease
the risk of serious side effects. Then, they will transplant stem cells purged
of T cells to lessen GVHD risk. If transplantation is successful, the researchers
can give patients donor T cells to enhance the graft-versus-malignancy effect.
"This approach involves balancing benefits and risks," said Dr. Dean.
"Decreasing the risks of haploidentical ASCT would make this treatment
available to more patients who lack a matched donor."
Who Can Join This Trial?
The researchers will recruit 6-10 patients aged 18 to 55 diagnosed with hematologic
malignancies or related conditions. See the complete
list of eligibility criteria.
Where Is This Trial Taking Place?
The trial is taking place at the NIH Clinical Center in Bethesda, Md.
Contact Information
For more information, contact the NCI Clinical Studies Support Center toll-free
at 1-888-NCI-1937. The call is confidential.
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