Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038831
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2002-06-05
Brief Title:
Allo Transplantation With Mylotarg Fludarabine and Melphalan for AML CML and MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Evaluation of Safety and Activity of Mylotarg Plus Melphalan and Fludarabine as Preparative Therapy for Older or Medically Infirm Patients Undergoing Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-07
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:
The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia chronic myelogenous leukemia or myelodysplastic syndrome
Primary Objective
1 To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related mismatched-related or matched unrelated donor transplantation
Secondary Objectives
1 To evaluate response rates engraftment kinetics and degree of chimerism achievable with this strategy
2 To evaluate the incidence and severity of GVHD in this population
3 To evaluate disease-free and overall survival and relapse rates
Primary Objective
1 To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related mismatched-related or matched unrelated donor transplantation
Secondary Objectives
1 To evaluate response rates engraftment kinetics and degree of chimerism achievable with this strategy
2 To evaluate the incidence and severity of GVHD in this population
3 To evaluate disease-free and overall survival and relapse rates
Detailed Description:
Before treatment starts patients will have a complete physical exam including blood and urine tests Patients will have a chest x-ray heart scan lung function test and a bone marrow biopsy Women who are able to have children will have a pregnancy test
In this study patients will receive Mylotarg twelve days before the transplant The first patients will receive Mylotarg at the lowest dose level As the study continues the dose levels will be increased as long as no severe side effects occur Mylotarg may be given in the outpatient Ambulatory Treatment Center ATC Patients will be monitored in the ATC for eight hours on the day of infusion For the next 5 days patients will be evaluated in the Clinic on a daily basis or as per physician orders One week before the transplant all patients will be admitted to the hospital and will continue their treatment as inpatients Patients experiencing side effects from their leukemia or leukemia treatment may need to be hospitalized earlier
On the 1st day of hospitalization patients will receive fluids by vein On the 5th 4th 3rd and 2nd day before the transplant patients will receive Fludarabine by vein Melphalan will be given by vein on the 2nd day before transplant Patients receiving five out of six antigen matched or unrelated bone marrow will also receive antithymocyte globulin by vein on the 3rd 2nd and 1st day before transplant
On the 7th day healthy blood stem cells or bone marrow from the donor will be given through the central catheter Some donor bone marrow or stem cells may be saved for future therapies
Patients will also receive several other medications to help the treatment work and to help prevent infections while their immune system is weak Tacrolimus and methotrexate will be given to prevent graft-versus-host disease GVHD GVHD occurs when the donors immune cells fight the patients body The Tacrolimus will be started on the day before the transplant and will continue for up to six months Tacrolimus is given by vein at first and then by mouth when patients are able to eat Methotrexate is given by vein on days 1 3 6 and possibly on day 11 after the transplant
Sulfamethoxazole Bactrim or pentamidine will be given to fight bacteria Bactrim is given by mouth when the counts are good Pentamidine is given by vein when the counts are low Acyclovir will be given at first by vein and then Valtrex will be given by pill to prevent viral infections Granulocyte colony-stimulating factor G-CSF will be given to help the new bone marrow grow It is given as an injection under the skin beginning on the 7th day after the transplant It will continue until the patients white blood cells reach an acceptable level Overall some of these drugs will be given for as long as 6 months or possibly longer Other medications may be necessary If you are allergic to some of these drugs changes will be made
Patients will be in the hospital for about 3-4 weeks Patients will have checkups every day until discharged from the hospital then 3 times a week until their blood counts improve Patients will then be seen by their doctor at least every week until 100 days after the bone marrow transplant Patients must stay in Houston during this time After 100 days patients will return at least every 3 months for the first year then every 6 months for an additional two years
Bone marrow samples will be taken at about 1 month 3 months 6 and 12 months after the transplant
This is an investigational study All of the drugs in this study are approved by the FDA About 47 patients will take part in this study All will be enrolled at M D Anderson
In this study patients will receive Mylotarg twelve days before the transplant The first patients will receive Mylotarg at the lowest dose level As the study continues the dose levels will be increased as long as no severe side effects occur Mylotarg may be given in the outpatient Ambulatory Treatment Center ATC Patients will be monitored in the ATC for eight hours on the day of infusion For the next 5 days patients will be evaluated in the Clinic on a daily basis or as per physician orders One week before the transplant all patients will be admitted to the hospital and will continue their treatment as inpatients Patients experiencing side effects from their leukemia or leukemia treatment may need to be hospitalized earlier
On the 1st day of hospitalization patients will receive fluids by vein On the 5th 4th 3rd and 2nd day before the transplant patients will receive Fludarabine by vein Melphalan will be given by vein on the 2nd day before transplant Patients receiving five out of six antigen matched or unrelated bone marrow will also receive antithymocyte globulin by vein on the 3rd 2nd and 1st day before transplant
On the 7th day healthy blood stem cells or bone marrow from the donor will be given through the central catheter Some donor bone marrow or stem cells may be saved for future therapies
Patients will also receive several other medications to help the treatment work and to help prevent infections while their immune system is weak Tacrolimus and methotrexate will be given to prevent graft-versus-host disease GVHD GVHD occurs when the donors immune cells fight the patients body The Tacrolimus will be started on the day before the transplant and will continue for up to six months Tacrolimus is given by vein at first and then by mouth when patients are able to eat Methotrexate is given by vein on days 1 3 6 and possibly on day 11 after the transplant
Sulfamethoxazole Bactrim or pentamidine will be given to fight bacteria Bactrim is given by mouth when the counts are good Pentamidine is given by vein when the counts are low Acyclovir will be given at first by vein and then Valtrex will be given by pill to prevent viral infections Granulocyte colony-stimulating factor G-CSF will be given to help the new bone marrow grow It is given as an injection under the skin beginning on the 7th day after the transplant It will continue until the patients white blood cells reach an acceptable level Overall some of these drugs will be given for as long as 6 months or possibly longer Other medications may be necessary If you are allergic to some of these drugs changes will be made
Patients will be in the hospital for about 3-4 weeks Patients will have checkups every day until discharged from the hospital then 3 times a week until their blood counts improve Patients will then be seen by their doctor at least every week until 100 days after the bone marrow transplant Patients must stay in Houston during this time After 100 days patients will return at least every 3 months for the first year then every 6 months for an additional two years
Bone marrow samples will be taken at about 1 month 3 months 6 and 12 months after the transplant
This is an investigational study All of the drugs in this study are approved by the FDA About 47 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