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Clinical Trials |
-2a1
Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, Maryland 20852 [T. A. D.]; Fred Hutchinson Cancer Research Center, Seattle, Washington 98104 [D. G. M.]; IDEC Pharmaceuticals Corp., San Diego, California 92121 [A. J. G-L., C. A. W., S. D.], University of Virginia Health Sciences Center, Charlottesville, Virginia 22908 [M. E. W.], University of Iowa, Iowa City, Iowa 52242 [G. J. W.]; and Stanford University Medical Center, Stanford, California 94305 [R. L.]
Rituximab
and IFN have each demonstrated single-agent activity in patients with
low-grade non-Hodgkin’s lymphoma (NHL). A single-arm, multicenter,
Phase II trial was conducted to assess the safety and efficacy of
combination therapy with rituximab and IFN-
-2a in 38 patients with
relapsed or refractory, low-grade or follicular, B-cell NHL. IFN--2a
[2.5 or 5 million units (MIU)] was administered s.c., three times
weekly for 12 weeks. Starting on the fifth week of treatment, rituximab
was administered by i.v. infusion (375 mg/m2) weekly for 4
doses. All 38 patients received four complete infusions of rituximab
and were evaluable for efficacy, although 11 patients (29%) did not
receive all 36 injections of IFN. The mean number of IFN--2a
injections was 31 doses; the mean total units received were 141 MIU
(maximum, 180 MIU). The study treatment was reasonably well tolerated
with no unexpected toxicities stemming from the combination therapy. No
grade 4 events were reported. Frequent adverse events during the
treatment period included asthenia (35 of 38 patients), chills (31 of
38), fever (30 of 38), headache (28 of 38), nausea (23 of 38), and
myalgia (22 of 38). The overall response rate was 45% (17 of 38
patients); 11% had a complete response, and 34% had a partial
response. The Kaplan-Meier estimates for the median response duration
and the median time to progression in responders are 22.3 and 25.2
months, respectively. Further follow-up is needed to determine whether
this treatment combination leads to a significantly longer time to
progression than single-agent treatment with rituximab.
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