Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

Completed · Phase 2

Conditions studied: Untreated Mantle Cell Lymphoma

In brief

Primary Objective 1\. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL. 2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Key facts

Study ID

NCT00401817

Run by

Weill Medical College of Cornell University

People needed

11

Starts

2007-11-01

Expected to finish

2013-11-01

Last updated by the study team

2017-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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