Trial Information
Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination
OBJECTIVES:
- Determine the tolerability and toxicity of rituximab combined with vinorelbine in
patients with relapsed non-Hodgkin's lymphoma following autologous peripheral blood
stem cell transplantation.
- Assess the response rate and duration of response to this regimen in these patients.
OUTLINE: Patients receive rituximab IV weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine
IV on weeks 2-4, 6-8, and 10-12. Patients who achieve partial response may continue on
vinorelbine from week 14 until disease progression.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Inclusion Criteria:
- Patients with B-cell Lymphoma, relapsing after high dose chemotherapy and autologous
stem cell transplantation or allogeneneic stem cell or bone marrow transplant
- Age > 18 years old
- Adequate hematologic function, as manifested by ANC > 1000/mm3 and platelet count >
40,000/mm3
- PS WHO: < 3
Exclusion Criteria:
- Patients with serum creatinine > 2 mg%, transaminases (ALT, AST) > 3 times upper
normal value, direct bilirubin > 2 mg%, unless they result from tumor involvement
- Pregnant or lactating females
- History of myelodysplastic syndrome
- Uncontrolled CNS disease
- Active serious infection
- History of refractoriness to vinorelbine. However, prior treatment with rituxan is
not an exclusion (synergy may still occur)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tolerability and toxicity
Outcome Description:
To define the tolerability and toxicity of a combination regimen of rituxan combined with vinorelbine for the treatment of B-cell NHL, relapsing after autologous stem cell transplantation.
Outcome Time Frame:
13 weeks
Safety Issue:
Yes
Principal Investigator
Christos E. Emmanouilides, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067163
NCT ID:
NCT00003963
Start Date:
May 1999
Completion Date:
February 2005
Related Keywords:
- Lymphoma
- Waldenstrom macroglobulinemia
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
|---|
| Jonsson Comprehensive Cancer Center, UCLA |
Los Angeles, California 90095-1781 |
