A total of 77 patients have been entered into
an ongoing, randomized protocol integrating rituximab (Rituxan) with
chemotherapy for patients with newly diagnosed stage IV indolent
lymphoma. Patients are receiving FND (fludarabine, Novantrone, and
dexamethasone) concurrently with rituximab in one arm and FND
followed by rituximab in the other arm. All patients have received
prophylaxis for Pneumocystis infection. A subset of
patientsthose with follicular lymphoma but no detectable bcl-2
gene rearrangementare considered prognostically adverse
(Lopez-Guillermo et al: Blood 93:308-3087, 1999) and are being
managed with an alternating triple therapy (ATT) 10-drug regimen (Ann
Oncol 5(suppl 2):S73, 1994).
Preliminary safety data are as follows:
There have been no grade 4 infections or nonhematologic toxicities.
The six grade 3 infections included two catheter-related bacteremias,
two other bacterial infections, and two fevers of unknown origin that
responded to antibacterial therapy. There have been no unusual
opportunistic infections; there has been one episode of localized
CONCLUSION: It appears that the combination of FND and rituximab,
administered either concurrently or sequentially, is a safe regimen.