Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Multicentre Phase II Trial of Bendamustine in Combination With Rituximab for Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia. CLL2M Protocol of the German CLL-Study Group (GCLLSG)
CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic benefits of using bendamustine in combination with rituximab for the treatment of patients with previously untreated or relapsed CLL.
Conventional chemotherapy and also high dose chemotherapy with autologous stem cell
transplantation are not curative treatment options in B-CLL; nearly all patients will
eventually relapse. Also monoclonal antibodies are not curative for B-CLL patients in
monotherapy, their impact on survival in combination with conventional chemotherapy is
currently validated. In addition, there is no standard combination therapy for patients with
relapsed CLL. Therefore there is an urgent medical need to identify new strategies.
The combination of rituximab (monoclonal antibody) and bendamustine (chemotherapy) has shown
encouraging activity in patients with relapsed/refractory NHL or mantle cell lymphoma. In
vitro studies have been used to investigate the effects of bendamustine and rituximab on
programmed cell death (apoptosis) and have shown synergistic effects of both drugs. The
mechanisms of action of these two active drugs may provide a treatment with good therapeutic
potential in CLL. However, though bendamustine has been used for over 30 years there is still
a need to define a standard regimen for the use of bendamustine in combination with
monoclonal antibodies (mAb) especially in the treatment of CLL.
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