Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00138164|
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : May 30, 2013
RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to non-Hodgkin's lymphoma cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: denileukin diftitox||Phase 2|
- Determine the efficacy of denileukin diftitox, in terms of objective response and time to progression, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
- Determine the safety of this drug in these patients.
- Determine the 1-year overall survival of patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, and 99 (weeks 1-16) in the absence of disease progression or unacceptable toxicity. Patients achieving a partial response at week 16 may continue treatment once monthly for up to 8 additional doses or until a complete response (CR) is achieved. Patients achieving a CR (at any time) receive 2 additional monthly doses of denileukin diftitox beyond CR.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||November 2008|
- Objective clinical response (complete or partial response)
- Time to progression
- Overall survival at 1 year
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): NCT00138164
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Lauren C. Pinter-Brown, MD||Jonsson Comprehensive Cancer Center|