Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00014664|
Recruitment Status : Unknown
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 10, 2003
Last Update Posted : December 18, 2013
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different monoclonal antibody regimens in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: apolizumab||Phase 2|
- Compare the relative safety of 3 different regimens of monoclonal antibody Hu1D10 in patients with relapsed or refractory grade I, II, or III B-cell non-Hodgkin's lymphoma.
- Compare the preliminary tumor response and progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive monoclonal antibody (MOAB) Hu1D10 IV over approximately 2 hours on days 1, 8, 15, and 22.
- Arm II: Patients receive MOAB Hu1D10 as in arm I at a higher dose.
- Arm III:Patients receive MOAB Hu1D10 IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at weeks 1, 4, and 12 and then at months 6, 9, 12, 18, and 24.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II, Open-Label, Randomized, Multicenter Trial To Evaluate The Preliminary Safety And Efficacy of Hu1D10 In Patients With Relapsed Or Refractory Grades I, II, or III B-Cell Non-Hodgkin's Lymphoma (Including Follicular, Small Lymphocytic And Marginal Zone/MALT)|
|Study Start Date :||October 2000|
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): NCT00014664
|United States, California|
|Protein Design Labs, Inc.|
|Freemont, California, United States, 94555|
|Study Chair:||Tillman Pearce, MD||Facet Biotech|