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Phase II Trial of Rituximab in Patients With B-Cell Lymphoproliferative Disorders Associated With Pharmacologic Immunosuppression


Phase 2
3 Years
70 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Phase II Trial of Rituximab in Patients With B-Cell Lymphoproliferative Disorders Associated With Pharmacologic Immunosuppression


OBJECTIVES: I. Evaluate the efficacy of rituximab in patients with B-cell
lymphoproliferative disorders while under pharmacologic immune suppression for control of
either allograft rejection or autoimmune disease. II. Evaluate the safety and direct
toxicity of rituximab in this patient population, including the potential for opportunistic
infections. III. Evaluate the secondary consequences of rituximab therapy in this
population, including changes in the requirement for immunosuppressive drugs, effects on
graft rejection, graft survival, and severity of autoimmune disease.

OUTLINE: Patients receive rituximab IV over several hours. Treatment repeats every week for
4 courses. Patients are followed every month for 6 months, and then every 3 months until
relapse or 2 years.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Polyclonal or monoclonal B-cell lymphoproliferative disorder
while under pharmacologic immune suppression for control of either allograft rejection or
autoimmune disease Measurable disease as defined by one of the following: At least 1 tumor
mass measuring 1.0 cm in largest dimension Greater than 25% marrow involvement
Quantifiable extranodal disease Expression of CD20 antigen confirmed by biopsy or fine
needle aspirate Progression of disease or stable disease following reduction of
immunosuppressive medication and antiviral therapy Inability to further reduce
immunosuppressive medication

PATIENT CHARACTERISTICS: Age: 3 to 70 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3
Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Not specified
Cardiovascular: No congestive heart failure Pulmonary: No pneumonitis Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
during and for 3 months after study No serious nonmalignant disease No active uncontrolled
bacterial, viral, or fungal infections

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine
therapy: At least 2 weeks since change in dosing and type of immunosuppressive drugs
unless due to progression of disease Radiotherapy: At least 4 weeks since prior
radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior major
surgery (except diagnostic surgery) Other: At least 30 days or 5 half-lives since other
prior investigational drugs or whichever is longer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sandra J. Horning, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000066825

NCT ID:

NCT00003716

Start Date:

March 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • childhood Burkitt lymphoma
  • childhood immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • Lymphoma
  • Lymphoproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Stanford University Medical CenterStanford, California  94305-5408