Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038805
Status:
TERMINATED
Last Update Posted:
2018-10-31
First Post:
2002-06-05
Brief Title:
Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia AML Acute Lymphocytic Leukemia ALL Chronic Myeloid Leukemia CML and Myelodysplastic Syndrome MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation Using Mylotarg CMA-676 Plus Nonmyeloablative Chemotherapy in Older or Medically Infirm Patients With High-Risk Acute Leukemia ALL Chronic Myelogenous Leukemia CML or Myelodysplastic Syndrome MDS
Status:
TERMINATED
Status Verified Date:
2018-10
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:
Primary Objective
To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but nonmyeloablative preparative regimen in older or medically infirm patients undergoing mini-allogeneic peripheral blood stem cell transplantation
Secondary Objectives
1 To evaluate response rates engraftment kinetics and degree of chimerism achievable with this strategy
2 To evaluate disease-free and overall survival and relapse rates
3 To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and mobilized DLI in patients not achieving complete remission
To determine the safety and maximum tolerated dose of CMA-676 as part of an intensive but nonmyeloablative preparative regimen in older or medically infirm patients undergoing mini-allogeneic peripheral blood stem cell transplantation
Secondary Objectives
1 To evaluate response rates engraftment kinetics and degree of chimerism achievable with this strategy
2 To evaluate disease-free and overall survival and relapse rates
3 To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and mobilized DLI in patients not achieving complete remission
Detailed Description:
Mylotarg is a novel immunoconjugate directed against the CD33 antigen found on most leukemia cells This humanized murine IgG4 monoclonal antibody is tagged with the toxin calicheamicin In equal molar concentrations calicheamicin is about 3200 times more potent than adriamycin In a Phase I study involving adult patients with relapse AML Mylotarg has been shown to have significant anti-leukemia activity with little toxicity The most concerning side effects of Mylotarg were prolonged neutropenia and thrombocytopenia Phase II studies have also demonstrated good efficacy with little toxicity
The goal of this proposal is to include Mylotarg in a nonmyeloablative preparative regimen similar to FAI used at MD Anderson Cancer Center The hypothesis is that Mylotarg will provide potent anti-leukemic effects without adding toxicity to the mini-allogeneic bone marrow transplant regimen A more potent anti-leukemic response may increase the complete remission rates and induce a state of minimal residual disease MRD Therefore the Graft vs Leukemia GVL effect of allogeneic transplantation will have a better chance for success In addition the administration of donor cells after Mylotarg should ameliorate the cytopenias previously associated with Mylotarg This medication likely will be well-tolerated
Patients with high-risk hematopoietic malignancies that express CD33 ie AML ALL CML and MDS will be included We will enroll older patients 55 years old or medically infirm patients who are unable to tolerate standard allogeneic bone marrow transplant Patients will be evaluated at 28 days post-transplant for evidence of response Those with residual disease may be eligible for additional Mylotarg given together with donor lymphocyte infusions Additional courses of Mylotarg may improve overall survival in this poor prognosis group
The goal of this proposal is to include Mylotarg in a nonmyeloablative preparative regimen similar to FAI used at MD Anderson Cancer Center The hypothesis is that Mylotarg will provide potent anti-leukemic effects without adding toxicity to the mini-allogeneic bone marrow transplant regimen A more potent anti-leukemic response may increase the complete remission rates and induce a state of minimal residual disease MRD Therefore the Graft vs Leukemia GVL effect of allogeneic transplantation will have a better chance for success In addition the administration of donor cells after Mylotarg should ameliorate the cytopenias previously associated with Mylotarg This medication likely will be well-tolerated
Patients with high-risk hematopoietic malignancies that express CD33 ie AML ALL CML and MDS will be included We will enroll older patients 55 years old or medically infirm patients who are unable to tolerate standard allogeneic bone marrow transplant Patients will be evaluated at 28 days post-transplant for evidence of response Those with residual disease may be eligible for additional Mylotarg given together with donor lymphocyte infusions Additional courses of Mylotarg may improve overall survival in this poor prognosis group
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