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Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

Primary Purpose

Untreated Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Rituximab
CHOP
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center
  • Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Response Rate
Overall Response Rate measured using Kaplan-Meier survival analysis Response criteria were those reported by Cheson et al. (1999)
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.
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.

Full Information

First Posted
November 20, 2006
Last Updated
September 15, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00401817
Brief Title
Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma
Official Title
Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Treatment Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
15 mg/kg on day 1 of each of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
CHOP
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Toxicity
Description
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.
Time Frame
38 months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall Response Rate measured using Kaplan-Meier survival analysis Response criteria were those reported by Cheson et al. (1999)
Time Frame
38 Months (min 33 months, max 62 months)
Title
Progression-Free Survival
Description
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.
Time Frame
3 years
Title
Overall Survival
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Leonard, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

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