S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00006020|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: nelarabine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)|
|Study Start Date :||July 2000|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||July 2004|
- Drug: nelarabine
1.5 gm/m2 IV over 2 hours days 1, 3, 5 q21 days
- CR [ Time Frame: After induction therapy is completed ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006020
|Study Chair:||Steven E. Coutre, MD||Stanford University|