Non-Hodgkin's Lymphoma
ECOG 2493
A Randomized Phase III Trial To Evaluate High-Dose Sequential Chemotherapy And Peripheral Blood Stem Cell Autologous Transplantation vs. CHOP As Initial Therapy For Patients With
Poor Risk Intermediate / High Grade Non-Hodgkin’s Lymphoma
Objectives:
1. To evaluate time to treatment failure / disease progression in patients with
high risk NHL randomized to receive HDS or CHOP as initial therapy. Evaluate
the CR rate and overall survival.
2. To determine toxicity of either HDS or CHOP as initial therapy in de novo
high risk NHL.
3. To evaluate potential occult disease in marrow, blood and peripheral blood
stem cell using molecular genetic techniques before, during, and following therapy.
Eligibility:
INITIAL INCLUSION / EXCLUSION:
1. Histologically confirmed poor-prognosis. NHL - intermediate high grade must have at least 2 of the following:
a.) Stage III or IV diagnosis
b.) LDH. Institution’s ULN
c.) ECOG PS 2-4
2. Must have at least one objective measurable disease parameter.
3. Pathology submission is required.
4. Must be <=65 years old and >=18 years old.
5. No prior chemotherapy or radiation therapy.
6. Must have adequate heme, renal, hepatic, cardiac, and pulmonary function.
7. No known HIV infection; no history of active angina, MI or major ventricular
arrythmia; no active infection; no concomitant malignancies; no history of hepatitis B or C infection, or positive hepatitis B or C antigen; no overt CNS involvement.
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