Anaplastic Large Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)
Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
I. Determine the complete and partial remission rates and remission duration in patients
with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell
lymphoma treated with 506U78.
II. Determine the safety and toxicity of this treatment regimen in this patient population.
OUTLINE:
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks
for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving complete response receive up to 8 courses of therapy.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until
relapse.
PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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