Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

NCT00401817 | Completed Phase 2 Results

• 1 other identifier: 0604008463
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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. 1.To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
2. 2.To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Conditions

Untreated Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Response Rate

  38 Months (min 33 months, max 62 months)

• Progression-Free Survival

  3 years

• Overall Survival

  3 years

Study Arms (1)

Study Treatment Arm

EXPERIMENTAL

Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles

Drug: Bevacizumab; Drug: Rituximab; Drug: CHOP

Interventions

Bevacizumab DRUG

15 mg/kg on day 1 of each of 6 cycles

Study Treatment Arm

Rituximab DRUG

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

Study Treatment Arm

CHOP DRUG

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

Study Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Bevacizumab; Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Results Point of Contact

• Title: John Leonard, MD
• Organization: Weill Cornell Medicine

amr2017@med.cornell.edu

646.962.2064

Study Officials

• John P Leonard, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2013
• Last Updated: October 20, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-09

Locations

US (2)