Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma
|ClinicalTrials.gov Identifier: NCT00863369|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : April 5, 2018
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with gemcitabine hydrochloride and rituximab may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and gemcitabine hydrochloride when given together with rituximab and to see how well they work in treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: bortezomib Drug: gemcitabine hydrochloride Other: questionnaire administration||Phase 1 Phase 2|
I. To evaluate the safety and feasibility of combining VELCADE (bortezomib) with gemcitabine (gemcitabine hydrochloride) in patients with recurrent lymphoma after standard therapy.
II. To define the maximum tolerated dose (MTD) of gemcitabine and Rituxan (rituximab) administered in combination with VELCADE given on a 21-day (old schema - Schema I) or 28-day (amended schema - Schema II) schedule.
I. To obtain preliminary data for response to this regimen in this patient population.
OUTLINE: This is a phase I, dose-escalation study of bortezomib and gemcitabine hydrochloride followed by a phase II study.
Patients receive bortezomib intravenously (IV), gemcitabine hydrochloride IV over 3-4 hours, and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of VELCADE in Combination With Gemcitabine in Relapsed B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date :||June 20, 2005|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Treatment (bortezomib, gemcitabine hydrochloride, rituximab)
Patients receive bortezomib IV, gemcitabine hydrochloride IV over 3-4 hours, and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: bortezomib
Other Names:Drug: gemcitabine hydrochloride
Other Names:Other: questionnaire administration
- Safety and feasibility [ Time Frame: One month after completion of study treatment ]
- Maximum tolerated dose [ Time Frame: One month after completion of study treatment ]
- Response [ Time Frame: One month after completion of study treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863369
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|Principal Investigator:||Leslie Popplewell, MD||City of Hope Medical Center|