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Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL



- Determine the 1-year progression-free survival rate in patients with bulky stage II or
stage III or IV diffuse large B-cell lymphoma treated with cyclophosphamide,
doxorubicin, vincristine, prednisone (CHOP) and rituximab in combination with


- Determine the response rate (complete response, complete unconfirmed response, and
partial response) and 2-year progression-free survival of patients treated with this

- Determine the toxic effects of this regimen in these patients.

- Correlate angiogenic biomarkers with outcome in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over
15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral
prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 6 months for 2
years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 18 months.

Inclusion Criteria


- Histologically confirmed* diffuse large B-cell lymphoma, meeting 1 of the following
stage criteria:

- Bulky stage II

- Stage III

- Stage IV NOTE: *Adequate sections from the original diagnostic specimen must be
available; needle aspiration or cytology are not considered adequate

- Bidimensionally measurable disease

- CD20-positive disease

- No prior indolent lymphoma, including histologic transformation or mixed histology
with an indolent or nodular component

- No clinical evidence of CNS involvement by lymphoma



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 100,000/mm^3

- No bleeding diathesis or coagulopathy


- Not specified


- Creatinine < 2 times upper limit of normal

- No proteinuria ≥ +1 by dipstick or urinalysis OR

- Urine protein:creatinine ratio < 1.0 OR

- Urine protein < 1 g by 24-hour urine collection


- No uncontrolled hypertension

- No myocardial infarction within the past 6 months

- No unstable angina within the past 6 months

- No stroke within the past 6 months

- No arterial thrombosis within the past 6 months

- No clinically significant peripheral vascular disease

- Ejection fraction ≥ 45% by MUGA or 2-dimensional echocardiogram (2-D ECHO)

- No significant cardiac abnormality by MUGA or 2-D ECHO


- No requirement for continuous supplemental oxygen


- No abdominal fistula within the past 6 months

- No gastrointestinal perforation within the past 6 months

- No intra-abdominal abscess within the past 6 months


- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy

- No known HIV positivity

- No history of hypersensitivity reaction to products containing polysorbate 20 (Tween
20), Chinese hamster ovary cell products, or recombinant human antibodies

- No traumatic injury within the past 28 days

- No serious or non-healing wound, ulcer, or bone fracture

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission


Biologic therapy

- No prior antibody-based therapy for lymphoma


- No prior chemotherapy for lymphoma

Endocrine therapy

- Not specified


- No prior radiotherapy for lymphoma


- More than 28 days since prior and no concurrent major surgery

- No prior solid organ transplantation


- Concurrent full-dose anticoagulants allowed for treatment of venous thrombosis
provided the following criteria are met:

- INR in range (i.e., 2-3)

- Patient is on a stable dose of warfarin or low molecular weight heparin

- No bleeding or pathological condition that would confer a high risk of bleeding
(e.g., tumor involving major vessels or known varices)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival at 1 Year

Outcome Description:

Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date

Outcome Time Frame:

0-1 year

Safety Issue:


Principal Investigator

Alison T. Stopeck, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse



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