NCT00005601

Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 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. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Determine response rate to cisplatin, cytarabine, and dexamethasone (DHAP) plus rituximab in patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma. * Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen. * Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen. OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study within 11 months.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
DRUG	cisplatin
DRUG	cytarabine
DRUG	dexamethasone
DRUG	sargramostim

Timeline

• Start date: 2000-10-01
• Primary completion: 2003-07-01
• Completion: 2008-02-01
• First posted: 2003-01-27
• Last updated: 2016-12-07

Locations

21 sites across 2 countries: United States, Canada