Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

Untreated Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401817
• Other study ID #: 0604008463
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2006
• Last updated: September 15, 2017
• Start date: November 2007
• Est. completion date: November 2013

Study information

• Verified date: September 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bevacizumab
15 mg/kg on day 1 of each of 6 cycles
• Rituximab
Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles. The dose to be administered is: Rituximab: 375 mg/m2
• CHOP
Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Toxicity	Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.	38 months
Secondary	Overall Response Rate	Overall Response Rate measured using Kaplan-Meier survival analysis; Response criteria were those reported by Cheson et al. (1999)	38 Months (min 33 months, max 62 months)
Secondary	Progression-Free Survival	The percentage of patients who have not progressed at the three year time point.; The 3-year PFS rate was estimated based on the Kaplan-Meier analysis.	3 years
Secondary	Overall Survival	The percentage of patients who have survived at the three year time point.; The 3-year OS rate was estimated based on the Kaplan-Meier analysis.	3 years

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