Follicular Lymphoma Clinical Trial
Official title:
Phase II of Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Patients With Relapsed or Refractory Follicular Lymphoma
The purpose of this study is to determine the rate and duration of complete remission and molecular response in patients with relapsed/refractory follicular lymphoma, using a combined treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem cells (PBSC) mobilization and autotransplant.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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