Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423709
Status:
COMPLETED
Last Update Posted:
2012-01-24
First Post:
2007-01-16
Brief Title:
Allogeneic Blood Stem Cell Transplantation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2012-01
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:
1 To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkins disease HD
2 To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy
3 To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect
2 To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy
3 To assess the antitumor activity of this approach in high-risk HD patients and the possible presence of a graft-vs-HD effect
Detailed Description:
All patients in this study must have a plastic tube catheter inserted into a vein under the collarbone Drugs and stem cells will be given through this tube
Fludarabine will be given through the catheter once a day for four days Patients will also receive melphalan for two days through the catheter Patients receiving a transplant from a matched unrelated donor ie not a blood relative or a mismatched related donor ie a blood relative but not a full match will also receive antithymocyte globulin ATG once a day for three days ATG can help preventing graft-versus-host disease All patients are expected to need blood transfusions as part of this treatment
Beginning two days before the transplant tacrolimus will be given through the catheter It will be given 24 hours a day until the patient can swallow The patient will then swallow one or more tacrolimus pills a day for about 6 months
On the transplant day day 0 the stem cells or bone marrow obtained from the donor will be infused through the catheter transplant Drugs will be given to reduce the chance of allergic reactions Starting on day 7 after the transplant filgrastim will be given through a needle to increase the growth of white blood cells Methotrexate will be given by IV on days 136 11 after the transplant The patient may require blood transfusions for the following 2-4 weeks and sometimes longer
Patients with progressive growing Hodgkins disease after the transplant will initially be taken off their immunosuppressive medications tacrolimus corticosteroids If there is no response to this maneuver they will be considered for infusion of additional cells from their donors with or without preceding chemotherapy Both these maneuvers may produce a response shrinkage of the tumor Patients with persistent but stable not growing disease may also be treated in a similar fashion Potential side effects of the infusion of additional cells include graft-versus-host disease and or a generalized drop in the blood counts Both of these conditions can be serious or life-threatening
Blood urine bone marrow and x-ray examinations will be performed as necessary to monitor the results of bone marrow transplantation Patients may require blood and platelet transfusions Blood tests will be done daily while hospitalized and several times a week until the blood counts recover Bone marrow aspiration and biopsies will be performed prior to the transplant when the donated cells show signs of engraftment and at other times during the next 1 to 3 years to evaluate the growth of the transplant marrow to evaluate possible recurrence of malignancy and recovery of immunity
This is an investigational study Up to 50 patients will be treated on this study If the initial results are discouraging the study may be stopped after a minimum of four patients have been enrolled
Fludarabine will be given through the catheter once a day for four days Patients will also receive melphalan for two days through the catheter Patients receiving a transplant from a matched unrelated donor ie not a blood relative or a mismatched related donor ie a blood relative but not a full match will also receive antithymocyte globulin ATG once a day for three days ATG can help preventing graft-versus-host disease All patients are expected to need blood transfusions as part of this treatment
Beginning two days before the transplant tacrolimus will be given through the catheter It will be given 24 hours a day until the patient can swallow The patient will then swallow one or more tacrolimus pills a day for about 6 months
On the transplant day day 0 the stem cells or bone marrow obtained from the donor will be infused through the catheter transplant Drugs will be given to reduce the chance of allergic reactions Starting on day 7 after the transplant filgrastim will be given through a needle to increase the growth of white blood cells Methotrexate will be given by IV on days 136 11 after the transplant The patient may require blood transfusions for the following 2-4 weeks and sometimes longer
Patients with progressive growing Hodgkins disease after the transplant will initially be taken off their immunosuppressive medications tacrolimus corticosteroids If there is no response to this maneuver they will be considered for infusion of additional cells from their donors with or without preceding chemotherapy Both these maneuvers may produce a response shrinkage of the tumor Patients with persistent but stable not growing disease may also be treated in a similar fashion Potential side effects of the infusion of additional cells include graft-versus-host disease and or a generalized drop in the blood counts Both of these conditions can be serious or life-threatening
Blood urine bone marrow and x-ray examinations will be performed as necessary to monitor the results of bone marrow transplantation Patients may require blood and platelet transfusions Blood tests will be done daily while hospitalized and several times a week until the blood counts recover Bone marrow aspiration and biopsies will be performed prior to the transplant when the donated cells show signs of engraftment and at other times during the next 1 to 3 years to evaluate the growth of the transplant marrow to evaluate possible recurrence of malignancy and recovery of immunity
This is an investigational study Up to 50 patients will be treated on this study If the initial results are discouraging the study may be stopped after a minimum of four patients have been enrolled
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