Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208923
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2005-09-13
Brief Title:
Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Allogeneic Bone Marrow Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies Using a Preparative Regimen of Busulfan Cyclophosphamide and Fludarabine
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who have cancer of the bone marrow leukemia or lymph gland lymphomas are being asked to take part in this study This study uses a new chemotherapy regimen and matched volunteer stem cell transplant to treat patients with cancers of this kind
Detailed Description:
Patients who have cancer of the bone marrow leukemia or lymph gland lymphomas are being asked to take part in this study This study uses a new chemotherapy regimen and matched volunteer stem cell transplant to treat patients with cancers of this kind
High dose chemotherapy followed by a transplant of stem cells collected from either bone marrow BMT or peripheral blood of an HLA tissue type matched unrelated donor offers a potential cure for several serious blood diseases including acute and chronic leukemia myelodysplastic syndrome and lymphoma
However the success of allogeneic unrelated volunteer matched donor transplant is limited by treatment related illness death and relapse in patients with refractory resistant disease andor advanced age older than 40 years
Patients being sought for this study do not have an HLA-matched relative to donate stem cell however through The National Marrow Donor Program or International Registries an HLA-matched unrelated donor has been found to donate stem cells Preliminary data shows that the outcome is comparable between bone marrow and peripheral blood stem cell transplantations and donor preference will determine which type of cells the patient receives
To carry out an unrelated transplant a normal person with similar HLA type must be available to donate cells The patient must be prepared to accept the donor cells by decreasing the bodys immune systems In addition the malignant cancerous cells must be destroyed to allow growth and repopulation of healthy donor cells This is usually done by giving total body irradiation and chemotherapy which is associated with severe side effects in patients over age 40
In other studies it has been found that treating the patient with two anticancer drugs Busulfan and Cyclophosphamide without total body irradiation is safe and sufficiently immunosuppressive High dose Busulfan and Cyclophosphamide are frequently used in combination prior to matched related bone marrow transplant in case of acute leukemia myelodysplastic syndrome MDS Hodgkins disease HD and chronic myeloid leukemia CML Fludarabine another anticancer drug suppresses the immune system and has strong anticancer effect against chronic lymphocytic leukemia CLL and non-Hodgkins lymphoma NHL Researchers are studying a new chemotherapy regimen that includes fludarabine along with busulfan and cyclophosphamide to provide more immunosuppression and anti-cancer effect without increasing the chemotherapy related toxicity in patients with CML acute leukemia and MDS CLL NHL and HD
The purposes of this study are 1 to decrease the side effects due to the chemotherapy used to treat the bone marrow and 2 to increase the number of tumor cells killed There will be up to 55 patients enrolled in this study at Emory University The expected duration of each subjects participation in this study will be for two years
High dose chemotherapy followed by a transplant of stem cells collected from either bone marrow BMT or peripheral blood of an HLA tissue type matched unrelated donor offers a potential cure for several serious blood diseases including acute and chronic leukemia myelodysplastic syndrome and lymphoma
However the success of allogeneic unrelated volunteer matched donor transplant is limited by treatment related illness death and relapse in patients with refractory resistant disease andor advanced age older than 40 years
Patients being sought for this study do not have an HLA-matched relative to donate stem cell however through The National Marrow Donor Program or International Registries an HLA-matched unrelated donor has been found to donate stem cells Preliminary data shows that the outcome is comparable between bone marrow and peripheral blood stem cell transplantations and donor preference will determine which type of cells the patient receives
To carry out an unrelated transplant a normal person with similar HLA type must be available to donate cells The patient must be prepared to accept the donor cells by decreasing the bodys immune systems In addition the malignant cancerous cells must be destroyed to allow growth and repopulation of healthy donor cells This is usually done by giving total body irradiation and chemotherapy which is associated with severe side effects in patients over age 40
In other studies it has been found that treating the patient with two anticancer drugs Busulfan and Cyclophosphamide without total body irradiation is safe and sufficiently immunosuppressive High dose Busulfan and Cyclophosphamide are frequently used in combination prior to matched related bone marrow transplant in case of acute leukemia myelodysplastic syndrome MDS Hodgkins disease HD and chronic myeloid leukemia CML Fludarabine another anticancer drug suppresses the immune system and has strong anticancer effect against chronic lymphocytic leukemia CLL and non-Hodgkins lymphoma NHL Researchers are studying a new chemotherapy regimen that includes fludarabine along with busulfan and cyclophosphamide to provide more immunosuppression and anti-cancer effect without increasing the chemotherapy related toxicity in patients with CML acute leukemia and MDS CLL NHL and HD
The purposes of this study are 1 to decrease the side effects due to the chemotherapy used to treat the bone marrow and 2 to increase the number of tumor cells killed There will be up to 55 patients enrolled in this study at Emory University The expected duration of each subjects participation in this study will be for two years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None