Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Combination Lenalidomide (Revlimid®) With Rituximab in Subjets With Relapsed or Refractory Diffuse Large b Cell Non-Hodgkin's Lymphoma.
The incidence of non-Hodgkin's lymphoma (NHL) is steadily increasing worldwide. At present,
it is the sixth most commonly diagnosed cancer in France, with 10 000 estimated new cases and
5200 deaths annually. An increasing NHL incidence at a rate of 3-4% per year was observed for
the 1970s and 1980s. This stabilized in the 1990s, nevertheless still with an annual rise of
1-2%, resulting in almost a doubling of the NHL incidence during last 40 years. This rise has
been noted worldwide, particularly in elderly persons >55 years. Increases in high-grade NHL
and extranodal disease are predominant. There is about 80% of B-cell histology, approximately
90% of follicular lymphomas and about 70% of aggressive lymphoma patients present with
disseminated disease at diagnosis. The prognosis of NHL depends on the histological type,
stage and treatment. Indolent lymphomas have a relatively good prognosis with survival time
as long as 10 years, but they are usually incurable in advanced stages. Aggressive NHL
constitutes about 50% of all cases of NHL in Western Europe. Approximately 50 - 60% of these
patients can be cured with immuno-chemotherapy regiments. Subsequently, almost 50% of
patients will eventually relapse or become refractory to treatment. The prognosis for
patients with refractory or relapsed aggressive NHL is generally poor. The response rates to
salvage therapy regimens range from 20 to 40%. Patients who present with refractory disease
have the worst prognosis, with a median survival of less than six months. Only a minority of
patients can be given high dose chemotherapy, the majority being ineligible due to disease
progression.
By modulating the immune system through dendritic cells and NK cells, by changing the
cytokine milieu, and by their anti-angiogenic effects, IMiDs in combination with mabthera
(rituximab) resulted in augmented in vitro and vivo antitumor effects against B-cell
lymphoma.
As concerns the timing of administration and doses of medications, phase I/II studies are
ongoing with R-CHOP in combination with Revlimid (Lenalidomide) in DLBCL. The latest
presentation is by Nowakowski et al. at ASCO meeting in June 2010. This study determined the
maximum tolerated dose of Revlimid(Lenalidomide)administered on days 1-10 with standard
R-CHOP (R2-CHOP). NO DLT was found and 25 mg of Revlimid(Lenalidomide)was the recommended
dose for phase II with enrollment of 32 patients. These encouraging results permit to
introduce in our much less toxic protocol 25 mg of Revlimid(Lenalidomide)as initial dose,
with progressive reduction in case of toxicity.
As regards the dose and timing of Mabthera(Rituximab), in DLBCL it was traditionally used as
a single 375 mg/m2 injection/cycle. Pre-clinical data suggests that for the optimal NK
enhancement Revlimid(Lenalidomide)must be administrated several days (approx. 7 days) before
Mabthera(Rituximab)injection. So, our protocol provides Mabthera(Rituximab)IV administration
at day 7 of Revlimid(Lenalidomide).
Performed parallel biological investigation of NK status will permit to confirm this
hypothesis with possible correction of timing and number of administrations of
Mabthera(Rituximab)par cycle.
n/a
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