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A Multi-Center, Phase I, Open Label, Two Arm, Non-Randomized, Dose-Escalation, Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Multi-Center, Phase I, Open Label, Two Arm, Non-Randomized, Dose-Escalation, Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma


- Determine the maximum tolerated dose of subcutaneous and IV CpG 7909 when administered
with rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

- Determine the safety and tolerability of this regimen in these patients.

- Determine the disease response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of CpG 7909. Patients are sequentially
assigned to 1 of 2 treatment groups.

- Group A: Patients receive rituximab IV over 4-5 hours followed by CpG 7909 IV over 2
hours on day 1. Courses repeat weekly for 4 weeks.

- Group B: Patients receive rituximab as above followed by CpG 7909 subcutaneously on day
1. Courses repeat weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per treatment group) will be accrued for
this study.

Inclusion Criteria


- Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma (NHL)

- CD20 positive by immunohistochemistry or flow cytometry

- Relapsed or refractory disease

- Bidimensionally measurable disease

- Sole site of measurable disease within a previously irradiated field allowed
provided there was disease progression at that site

- No pre-existing ascites or pleural effusions

- No known CNS involvement by NHL



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- More than 3 months


- Neutrophil count at least 1,000/mm3

- Platelet count at least 50,000/mm3


- Bilirubin less than 2 mg/dL

- Transaminase less than 2 times upper limit of normal

- No hepatitis B or C


- Creatinine less than 2 mg/dL


- No significant cardiovascular disease

- No New York Heart Association class III congestive heart failure

- No myocardial infarction within the past 6 months

- No unstable angina

- No uncontrolled atrial or ventricular cardiac arrhythmias


- No concurrent significant pulmonary disease


- HIV negative

- No acute infection requiring antibiotics

- No fever over 38.2 degrees C within the past 3 days

- No other malignancy within the past 5 years except basal cell or noninvasive squamous
cell skin cancer or carcinoma in situ of the cervix

- No pre-existing autoimmune disease or antibody-mediated disease, including:

- Systemic lupus erythematosus

- Rheumatoid arthritis

- Multiple sclerosis

- Sjogren's syndrome

- Autoimmune thrombocytopenia

- Controlled thyroid disease allowed

- Concurrent autoantibodies without clinical autoimmune disease allowed

- No history of allergic reactions attributed to compounds of similar composition to
study drugs

- No other medical history, including laboratory results, that would preclude study

- No suspected or confirmed poor compliance or mental instability that would preclude

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No prior allogeneic transplantation

- More than 30 days since prior hematopoietic growth factors (e.g., filgrastim (G-CSF)
or epoetin alfa)

- More than 30 days since prior immunotherapy

- More than 90 days since prior monoclonal antibodies as monotherapy for patients who
were unresponsive to treatment (30 days for patients who responded to treatment and
subsequently relapsed)

- No other concurrent biological agents

- No concurrent hematopoietic growth factors (e.g., G-CSF or epoetin alfa)


- More than 30 days since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy:

- More than 30 days since prior systemic corticosteroids

- No concurrent systemic corticosteroids


- See Disease Characteristics

- More than 30 days since prior radiotherapy

- No concurrent radiotherapy


- Not specified


- Recovered from prior therapy

- At least 6 months since prior coronary angioplasty

- More than 30 days since prior immunosuppressants

- More than 30 days since prior participation in an investigational drug study

- No concurrent immunosuppressants

- No concurrent anticoagulants except aspirin at doses no greater than 325 mg/day

- No other concurrent anticancer therapy

- No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • 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



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781