Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System
Status:
Completed
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
Background:
Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of
suitable donors for patients without a human leukocyte-antigen (HLA) tissue-matched sibling
and graft-versus-host disease (GVHD), a serious side effects of immune-suppressing
chemotherapy that is given to bring the cancer under control before SCT. In GVHD, the
patients immune system attacks the transplanted donor cells.
This study will try to improve the results of SCT from unrelated HLA-matched donors using
targeted immune-depleting chemotherapy to bring the cancer under control before
transplantation and to lower the chance of graft rejection, followed by reduced-intensity
transplant chemotherapy to make the procedure less toxic.
Objectives:
To evaluate the safety and effectiveness of targeted immune-depleting chemotherapy followed
by reduced-intensity transplant chemotherapy in patients with advanced cancers of the blood
and immune system.
To evaluate the safety and effectiveness of two different drug combinations to prevent GVHD.
Both regimens have been successful in preventing GVHD, but they work by different mechanisms
and affect the rebuilding of the immune system after the transplant.
Eligibility:
People 18 to 74 years of age with advanced or high-risk cancers of the blood and immune
system who do not have a suitable HLA-matched sibling.
Design:
All patients receive chemotherapy before transplant to treat the cancer and suppress immune
function.
All patients receive a conditioning regimen of cyclophosphamide for 4 days and fludarabine
for 4 days before SCT to prepare for the transplant.
Patients are randomly assigned to one of two combination drug treatments to prevent GHVD as
follows:
- Group 1: Tacrolimus starting 3 days before SCT and continuing for 6 months, plus
methotrexate on days 1, 3, 6, and 11 post-SCT, plus sirolimus starting 3 days before the
SCT and continues for 6 months following SCT.
- Group 2: Alemtuzumab for 4 days starting 8 days before SCT, plus cyclosporine starting 1
day before SCT and continuing for 6 months.
Patients receive the donors stem cells and immune cells 2 days after completing the
conditioning regimen.
Patients are followed at the clinic regularly for the first 6 months after SCT, and then less
often for at least 5 years. Some visits may include bone marrow aspirates and biopsies, blood
draws, and other tests to monitor disease status.
A skin biopsy, oral mucosa biopsy, and saliva collection are done to study chronic GVHD.
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