Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499889
Status:
TERMINATED
Last Update Posted:
2012-04-23
First Post:
2007-07-10
Brief Title:
Imatinib Mesylate Busulfan Fludarabine and Antithymocyte Globulin for CML Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Imatinib Mesylate Busulfan Fludarabine Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Support issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To estimate the probability of molecular complete remission at one year for the described sequential treatment approach with nonablative hematopoietic transplantation post transplant imatinib mesylate and donor lymphocyte infusion in patients with Ph-positive Chronic Myelogenous Leukemia CML not in blastic transformation
Secondary Objective
Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease response to donor lymphocyte infusion DLI for residual disease following imatinib mesylate therapy as well as engraftment toxicity disease free survival and survival effect of busulfan pharmacokinetics on study outcome
To estimate the probability of molecular complete remission at one year for the described sequential treatment approach with nonablative hematopoietic transplantation post transplant imatinib mesylate and donor lymphocyte infusion in patients with Ph-positive Chronic Myelogenous Leukemia CML not in blastic transformation
Secondary Objective
Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease response to donor lymphocyte infusion DLI for residual disease following imatinib mesylate therapy as well as engraftment toxicity disease free survival and survival effect of busulfan pharmacokinetics on study outcome
Detailed Description:
Patients will have blood and bone marrow tests performed as well as chest and sinus X-rays and tests of their heart and lung function Approximately 5 tablespoons of blood will be drawn
All patients in this study will receive imatinib mesylate by mouth for 9 days unless the patient is known to be allergic or have symptomatic intolerance to the drug or if the leukemia has failed to respond to imatinib Fludarabine 40 mgm2 by vein for 4 days days -5 to -2 busulfan 130 mgm2 by vein for 2 days days -3 and -2 and ATG Antithymocyte Globulin 25 mgkg by vein for 3 days -3-2 and -1
Patients will then receive the donor bone marrow or blood stem cells by vein over approximately one hour on day 0
After the infusion of the donor cells you will receive immunosuppressive therapy with tacrolimus and methotrexate to decrease the risk of developing graft-vs-host disease GvHD
Patients will need frequent blood tests to monitor their counts and blood chemistries This is generally done daily while in hospital and at least twice per week for the first 100 days post transplant You may need frequent blood transfusions and may have to be admitted to the hospital to receive antibiotics if they develop fever Bone marrow will be examined frequently beginning four weeks after treatment to evaluate response to treatment Blood and bone marrow exams are to be performed at one two three six 12 and 18 months post transplant and yearly thereafter for 5 years To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
Patients in whom treatment produces a remission in which no sign of the leukemia can be detected will receive no further therapy unless the leukemia recurs Patients with evidence of leukemia after 3 months from the transplant will receive additional treatment with imatinib mesylate those with detectable leukemia after an additional 3 months may receive an infusion of immune cells from the transplant donor
If there is evidence of leukemia after the transplant you will receive additional treatment with imatinib mesylate If leukemia cells can still be detected additional donor immune cells will be given to you by vein
Patients are considered on the study for 5 years after the transplant
A total of 90 patients will take part in this study All will be enrolled at M D Anderson
All patients in this study will receive imatinib mesylate by mouth for 9 days unless the patient is known to be allergic or have symptomatic intolerance to the drug or if the leukemia has failed to respond to imatinib Fludarabine 40 mgm2 by vein for 4 days days -5 to -2 busulfan 130 mgm2 by vein for 2 days days -3 and -2 and ATG Antithymocyte Globulin 25 mgkg by vein for 3 days -3-2 and -1
Patients will then receive the donor bone marrow or blood stem cells by vein over approximately one hour on day 0
After the infusion of the donor cells you will receive immunosuppressive therapy with tacrolimus and methotrexate to decrease the risk of developing graft-vs-host disease GvHD
Patients will need frequent blood tests to monitor their counts and blood chemistries This is generally done daily while in hospital and at least twice per week for the first 100 days post transplant You may need frequent blood transfusions and may have to be admitted to the hospital to receive antibiotics if they develop fever Bone marrow will be examined frequently beginning four weeks after treatment to evaluate response to treatment Blood and bone marrow exams are to be performed at one two three six 12 and 18 months post transplant and yearly thereafter for 5 years To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
Patients in whom treatment produces a remission in which no sign of the leukemia can be detected will receive no further therapy unless the leukemia recurs Patients with evidence of leukemia after 3 months from the transplant will receive additional treatment with imatinib mesylate those with detectable leukemia after an additional 3 months may receive an infusion of immune cells from the transplant donor
If there is evidence of leukemia after the transplant you will receive additional treatment with imatinib mesylate If leukemia cells can still be detected additional donor immune cells will be given to you by vein
Patients are considered on the study for 5 years after the transplant
A total of 90 patients will take part in this study All will be enrolled at M D Anderson
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