Overview

This trial is active, not recruiting.

Condition untreated mantle cell lymphoma
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor Weill Medical College of Cornell University
Start date November 2007
End date July 2011
Trial size 36 participants
Trial identifier NCT00401817, 0604008463

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
effect of bevacizumab + CHOP-rituximab on untreated mantle cell lymphoma
time frame: duration of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
Principal investigator John P Leonard, MD
Description 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 treatment 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.