NCT00006020

S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.

Detailed description

OBJECTIVES: * Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78. * Determine the frequency and severity of toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	nelarabine	1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days

Timeline

• Start date: 2000-07-01
• Primary completion: 2004-06-01
• Completion: 2004-07-01
• First posted: 2003-01-27
• Last updated: 2015-03-06

Locations

107 sites across 1 country: United States