Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003727
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
1999-11-01
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplantation Followed by Immunotherapy in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Autotransplantation for Chronic Myelogenous Leukemia CML Followed by Immunotherapy With Ex-Vivo Expanded Autologous T Cells
Status:
COMPLETED
Status Verified Date:
2019-10
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with a peripheral stem cell transplant and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE This phase II trial is studying giving chemotherapy together with a peripheral stem cell transplant followed by immunotherapy to see how well it works in treating patients with chronic phase chronic myelogenous leukemia
PURPOSE This phase II trial is studying giving chemotherapy together with a peripheral stem cell transplant followed by immunotherapy to see how well it works in treating patients with chronic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the feasibility of ex vivo expansion and reinfusion of autologous CD4 T cells after interferon therapy or high-dose chemotherapy with CD34-selected autologous peripheral blood stem cell rescue in patients with chronic phase chronic myelogenous leukemia CML
Determine the frequency of hematologic cytogenetic and molecular remissions of CML following infusion of ex vivo expanded T cells
OUTLINE Patients undergo mononuclear cell leukapheresis to obtain T cells for ex-vivo expansion preferably before they receive interferon alfa subcutaneously SC daily on a therapeutic trial
At least 1 month after interferon is stopped mobilization chemotherapy is administered Patients receive cyclophosphamide IV over 12 hours on day 0 etoposide IV over 2 hours on day 1 sargramostim GM-CSF SC on days 3 and 4 and filgrastim G-CSF SC beginning on day 5 Peripheral blood stem cells PBSC are collected by leukapheresis when blood cell counts have recovered
Approximately 2-3 weeks later high-dose chemotherapy begins Patients receive gemcitabine IV over 100 minutes on day -5 carmustine IV over 2 hours on day -2 followed 6 hours later by gemcitabine IV again and melphalan IV over 20 minutes on day -1 CD34 selected PBSCs are infused on day 0 at least 18 hours after melphalan administration Patients receive GM-CSF SC beginning on day 1 and continuing until blood cell counts recover
Patients then receive ex vivo expanded autologous T cells on day 14 after autotransplantation Interferon alfa is administered three times a week starting about 3 months after transplantation
Patients who only receive expanded T cells without high-dose chemotherapy and autotransplantation but show no response after 3 months may proceed to autotransplantation followed by a second ex vivo expanded T-cell infusion
Patients are followed at 1 2 3 6 9 and 12 months then every 6 months thereafter
PROJECTED ACCRUAL A total of 7-22 patients will be accrued for this study
Determine the feasibility of ex vivo expansion and reinfusion of autologous CD4 T cells after interferon therapy or high-dose chemotherapy with CD34-selected autologous peripheral blood stem cell rescue in patients with chronic phase chronic myelogenous leukemia CML
Determine the frequency of hematologic cytogenetic and molecular remissions of CML following infusion of ex vivo expanded T cells
OUTLINE Patients undergo mononuclear cell leukapheresis to obtain T cells for ex-vivo expansion preferably before they receive interferon alfa subcutaneously SC daily on a therapeutic trial
At least 1 month after interferon is stopped mobilization chemotherapy is administered Patients receive cyclophosphamide IV over 12 hours on day 0 etoposide IV over 2 hours on day 1 sargramostim GM-CSF SC on days 3 and 4 and filgrastim G-CSF SC beginning on day 5 Peripheral blood stem cells PBSC are collected by leukapheresis when blood cell counts have recovered
Approximately 2-3 weeks later high-dose chemotherapy begins Patients receive gemcitabine IV over 100 minutes on day -5 carmustine IV over 2 hours on day -2 followed 6 hours later by gemcitabine IV again and melphalan IV over 20 minutes on day -1 CD34 selected PBSCs are infused on day 0 at least 18 hours after melphalan administration Patients receive GM-CSF SC beginning on day 1 and continuing until blood cell counts recover
Patients then receive ex vivo expanded autologous T cells on day 14 after autotransplantation Interferon alfa is administered three times a week starting about 3 months after transplantation
Patients who only receive expanded T cells without high-dose chemotherapy and autotransplantation but show no response after 3 months may proceed to autotransplantation followed by a second ex vivo expanded T-cell infusion
Patients are followed at 1 2 3 6 9 and 12 months then every 6 months thereafter
PROJECTED ACCRUAL A total of 7-22 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1513 | None | None | None |
| MSGCC-9851 | None | None | None |
| MSGCC-1198006 | None | None | None |