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Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

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, UCLALos Angeles, California  90095-1781