Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366275
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2006-08-17
Brief Title:
Immunochemotherapy in Vivo Purging PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Phase II of Immunochemotherapy in Vivo Purging PBSC Mobilization and Autotransplant in Patients With Relapsed or Refractory Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-10
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:
The purpose of this study is to determine the rate and duration of complete remission and molecular response in patients with relapsedrefractory follicular lymphoma using a combined treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem cells PBSC mobilization and autotransplant
Detailed Description:
Autologous stem cell transplantation has been shown effective in the long-term control of follicular lymphoma Lymphoma however can progress after high-dose treatments Lymphoma cells have been proved to contaminate bone marrow and peripheral blood stem cells PBSC collections and may contribute to relapse after autotransplant The presence in peripheral blood and marrow of PCR-detectable cells bearing the bcl-2 rearrangement appeared to be a surrogate marker of disease and the achievement of a bcl-2 negative status is associated with a lower risk of recurrence Several methods have been attempted to abolish graft contamination in vitro treatment with cytotoxic agents in vitro treatment with anti-B-cell monoclonal antibodies and complement immunomagnetic beads positive selection of CD34 cells All these techniques usually produce loss of cells are time-consuming and expensive and neoplastic depletion is often partial with residual polymerase chain reaction PCR-positive cells in the graft
In the last years the chimeric anti-CD20 monoclonal antibody Rituximab has been shown to be an effective therapeutic option for low-grade lymphoma Owing to the different mechanism of action the synergism with cytotoxic agents and the non-overlapping toxicity Rituximab is an ideal drug for combination with chemotherapy On this basis Rituximab has been used during mobilisation procedures as a tool to obtain in vivo purging and collection of lymphoma-free progenitor cells In addition several studies have demonstrated that the efficiency of peripheral blood stem cells PBSC harvested is not adversely affected by Rituximab and that engraftment and all parameters of hematopoietic recovery are not compromised The incorporation of Rituximab into sequential high-dose therapy programs produced high rates of clinical and molecular remission in patients with indolent lymphoma indicating that the antibody has an additive effect on chemotherapy
In the last years the chimeric anti-CD20 monoclonal antibody Rituximab has been shown to be an effective therapeutic option for low-grade lymphoma Owing to the different mechanism of action the synergism with cytotoxic agents and the non-overlapping toxicity Rituximab is an ideal drug for combination with chemotherapy On this basis Rituximab has been used during mobilisation procedures as a tool to obtain in vivo purging and collection of lymphoma-free progenitor cells In addition several studies have demonstrated that the efficiency of peripheral blood stem cells PBSC harvested is not adversely affected by Rituximab and that engraftment and all parameters of hematopoietic recovery are not compromised The incorporation of Rituximab into sequential high-dose therapy programs produced high rates of clinical and molecular remission in patients with indolent lymphoma indicating that the antibody has an additive effect on chemotherapy
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 |
|---|---|---|---|
| LNH 1-02 | OTHER | IRCCS Policlinico San Matteo | None |