Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005787
Status:
TERMINATED
Last Update Posted:
2012-06-01
First Post:
2000-06-02
Brief Title:
Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per PI due to poorinadequate accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant
PURPOSE Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkins lymphoma and who will be treated with high-dose chemotherapy
PURPOSE Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkins lymphoma and who will be treated with high-dose chemotherapy
Detailed Description:
OBJECTIVES
Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells EVE PBMNC as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkins lymphoma
Compare the effect of EVE PBMNC on white blood cell red blood cell and platelet recovery in patients on this study vs historical controls matched by protocol disease status and prior therapy
Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo
Determine the relationships between length of culture immunophenotype and clinical outcome
Determine the required numbers of white blood cell precursors for clinical efficacy
Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period
OUTLINE Autologous peripheral blood mononuclear cells PBMNC are harvested Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand interleukin-3 filgrastim G-CSF sargramostim GM-CSF and epoetin alfa for 13 days Expanded PBMNC are reinfused on day 0
Patients are followed monthly for 1 year
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells EVE PBMNC as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkins lymphoma
Compare the effect of EVE PBMNC on white blood cell red blood cell and platelet recovery in patients on this study vs historical controls matched by protocol disease status and prior therapy
Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo
Determine the relationships between length of culture immunophenotype and clinical outcome
Determine the required numbers of white blood cell precursors for clinical efficacy
Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period
OUTLINE Autologous peripheral blood mononuclear cells PBMNC are harvested Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand interleukin-3 filgrastim G-CSF sargramostim GM-CSF and epoetin alfa for 13 days Expanded PBMNC are reinfused on day 0
Patients are followed monthly for 1 year
PROJECTED ACCRUAL A total of 24 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-G00-1734 | None | None | None |
| NU-99Z1 | None | None | None |