Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038870
Status:
WITHDRAWN
Last Update Posted:
2018-10-25
First Post:
2002-06-05
Brief Title:
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
Status:
WITHDRAWN
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Determine the feasibility of generation of autologous Acute Myelogenous Leukemia AML or Chronic Myelogenous Leukemia in myeloid blast crisis CMLBC derived dendritic cell activated lymphocytes DCAL in poor prognosis patients
2 Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes DCAL in patients with AML or CMLBC
3 Quantitate circulating immune effector cells in patients after infusion of DCAL
4 Record the efficacy of AML or CMLBC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with AML or CMLBC
2 Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes DCAL in patients with AML or CMLBC
3 Quantitate circulating immune effector cells in patients after infusion of DCAL
4 Record the efficacy of AML or CMLBC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with AML or CMLBC
Detailed Description:
Most patients relapsing with AML either fail to achieve second remission or have only brief remissions Patients more than 60 years of age or having histories of antecedent hematological disorders prior chemotherapy or poor risk cytogenetics have generally only short remissions and as a group have two year survivals of less than 10 Equally patients with myeloid blast crisis of CML often fail to achieve remission or have responses of only brief duration Laboratory studies have shown that AML leukemic blasts may be induced in culture to differentiate into dendritic cells which in turn may be used activate autologous lymphocytes to acquire leukemia specific cytotoxicity This trial will assess the feasibility of generation of dendritic cell activated lymphocytes and toxicity and efficacy of these activated cells given after reinduction chemotherapy Before this study begins some toxicity information will have been generated in a trial of similar cells given to CML patients
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