A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
- Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and
cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the validity and safety of this regimen as a mobilization regimen before
high-dose chemotherapy with stem cell support in these patients.
OUTLINE: This is an open-label, multicenter study.
- Salvage therapy: Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over
30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and
cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in
the absence of disease progression or unacceptable toxicity.
After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:
- Complete response (CR) or partial response (PR): Patients with a CR or PR who are
suitable candidates for autologous stem cell transplantation (ASCT) proceed to
mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who
are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6
courses in the absence of disease progression or unacceptable toxicity.
- Stable disease: Patients with stable disease continue to receive salvage therapy for up
to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who
are suitable candidates for ASCT proceed to mobilization therapy, high-dose
chemotherapy, and ASCT off study at the investigator's discretion.
- Mobilization therapy (optional regimen; regimen used for mobilization is at the
investigator's discretion): Patients receive rituximab* IV on days 1 and 7;
pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5;
cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes
on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily
beginning on day 7 and continuing until blood counts recover. Patients receive 1
or more courses of mobilization therapy during which stem cells are harvested.
Patients then proceed to high-dose chemotherapy and subsequent re-infusion of
harvested stem cells.
NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive
- High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per
institutional standard practice.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Julie M. Vose, MD
University of Nebraska
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|North Shore University Hospital||Manhasset, New York 11030|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Louisiana State University Health Sciences Center - Shreveport||Shreveport, Louisiana 71130-3932|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Markey Cancer Center at University of Kentucky Chandler Medical Center||Lexington, Kentucky 40536-0084|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University||Cleveland, Ohio 44106|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Baylor University Medical Center||Dallas, Texas 75246|
|Providence Cancer Center at Providence Portland Medical Center||Portland, Oregon 97213-2967|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|
|Cancer Centers of the Carolinas - Eastside||Greenville, South Carolina 29601|
|Piedmont Hematology-Oncology Associates||Winston-Salem, North Carolina 27103|
|Delaware Clinical & Laboratory Physicians||Newark, Delaware 19713|
|Rocky Mountain Cancer Centers - Denver Midtown||Denver, Colorado 80218|
|Gabrail Cancer Center - Canton Office||Canton, Ohio 44718|
|Pasco, Hernando Oncology Associates, P.A.||New Port Richey, Florida|
|Arizona Oncology Associates - Craycroft Road Offices||Tucson, Arizona 85712-2254|
|Rocky Mountain Cancer Centers - Colorado Springs||Colorado Springs, Colorado 80933-1181|
|Cancer Care Associates-West||Oklahoma City, Oklahoma 73112-4414|
|Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax||Fairfax, Virginia 22031|