This study is NOT currently recruiting participants.
Number
07-C-0195
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Max Age: 74
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Unrelated Donors; Reduced Intensity Stem Cell Transplant; Leukemia; Lymphoma; Allogeneic Stem Cell Transplant
Recruitment Keyword(s)
Lymphoma; Leukemia; Myelodysplastic Syndrome; Multiple Myeloma
Condition(s)
Myelodysplastic Syndrome; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Acute Leukemia; Multiple Myeloma
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Biological/Vaccine: Rituximab Drug: Cyclosporine Drug: Allogenic stem cell transplant (ASCT) Drug: Conditioning Chemotherapy Drug: TMS Drug: FLAG Drug: EPOCH-F Biological/Vaccine: Alemtuzumab
Supporting Site
National Cancer Institute
Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of suitable donors for patients without an 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 patient s 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 continuing through day 14 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 donor s stem cells and immune cells 2 days after 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.
--Back to Top--
ELIGIBILITY CRITERIA RECIPIENT ON STANDARD CARE THERAPY: -The patient is 18 74 years of age. -The patient has a potentially suitable 8/8 donor if they are between the ages of 69-74 years of age or a potentially suitable 8/8 or 7/8 unrelated donor(s) in the National Marrow Registry or Other Available Registry if they are between the ages of 18-74. -The patient currently does not meet the protocol s eligibility/enrollment criteria for any reason. -There is a high likelihood that the patient, in the opinion of the PI or LAI, will meet the protocol s eligibility/enrollment criteria to proceed to transplant after standard therapy is completed. -The patient or legal guardian is able to give informed consent. EXCLUSION CRITERIA RECIPIENT ON STANDARD CARE THERAPY: -HIV infection. There is theoretical concern that the degree of immune suppression associated with the treatment may result in progression of HIV infection. -Pregnant or lactating. Patients of childbearing potential must use an effective method of contraception. The effects of the chemotherapy, the subsequent transplant and the medications used after the transplant are highly likely to be harmful to a fetus. The effects upon breast milk are also unknown and may be harmful to the infant.
-The patient is 18 74 years of age.
-The patient has a potentially suitable 8/8 donor if they are between the ages of 69-74 years of age or a potentially suitable 8/8 or 7/8 unrelated donor(s) in the National Marrow Registry or Other Available Registry if they are between the ages of 18-74.
-The patient currently does not meet the protocol s eligibility/enrollment criteria for any reason.
-There is a high likelihood that the patient, in the opinion of the PI or LAI, will meet the protocol s eligibility/enrollment criteria to proceed to transplant after standard therapy is completed.
-The patient or legal guardian is able to give informed consent.
EXCLUSION CRITERIA RECIPIENT ON STANDARD CARE THERAPY:
-HIV infection. There is theoretical concern that the degree of immune suppression associated with the treatment may result in progression of HIV infection.
-Pregnant or lactating. Patients of childbearing potential must use an effective method of contraception. The effects of the chemotherapy, the subsequent transplant and the medications used after the transplant are highly likely to be harmful to a fetus. The effects upon breast milk are also unknown and may be harmful to the infant.
Principal Investigator
Referral Contact
For more information: