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Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)

Phase 2
18 Years
Open (Enrolling)
Untreated Mantle Cell Lymphoma

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Trial Information

Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)

Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles

Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)

Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of

Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months
for the first year post treatment, then every 6 months until disease progression or death
for years 2 through 5 post treatment. Patients who have disease progression will be
contacted every 6 months until death to assess for survival status.

Inclusion Criteria:

- Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with
characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+),
CD23(-) and CD10(-)

- Patient has not received any prior anti-cancer therapy for lymphoma

- Laboratory parameters (unless considered by investigator to be due to lymphoma):

Absolute neutrophil count > 1000 cells/mm3 Platelet count > 50,000 cells/mm3 Hemoglobin >
7 gm/dL Creatinine < 2.0 x ULN Total bilirubin < 2.0 x ULN

- Patient has at least one tumor mass > 1.5 cm in one dimension

- Available tumor tissue for correlative studies (rebiopsy to be performed if needed)

- Patient is > 18 years old

- Patient has KPS > 50%

- Patient has signed IRB-approved informed consent

- Patient agrees to use birth control for duration of study

Exclusion Criteria:

- Known central nervous system (CNS) involvement by lymphoma

- Known hepatitis infection

- Known HIV positivity

- Known history of renal disease with proteinuria; urine protein:creatinine ratio ³1.0
at screening

- Uncontrolled hypertension: blood pressure of >150/100 mmHg at screening

- Unstable angina

- History of myocardial infarction within 6 months

- History of stroke within 6 months

- Clinically significant peripheral vascular disease

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- Patient has ejection fraction < 50%

- Patient is taking coumadin, or has known history of thrombosis within last 6 months

- Evidence of bleeding diathesis or coagulopathy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1, anticipation of need for major surgical procedure during the course
of the study

- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to Day 1

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 1

- Serious, non-healing wound, ulcer, or bone fracture

- Concomitant malignancies or previous malignancies within the last five years, with
the exception of adequately treated basal or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix.

- Patient is pregnant or nursing

- Patient is receiving other investigational drugs

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

effect of bevacizumab + CHOP-rituximab on untreated mantle cell lymphoma

Outcome Time Frame:

duration of study

Safety Issue:


Principal Investigator

John P Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

July 2011

Related Keywords:

  • Untreated Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell



Rush University Medical Center Chicago, Illinois  60612-3824
Weill Medical College of Cornell University New York, New York  10021