Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cyclophosphamide

Mitoxantrone

Vincristine

Prednisone

Rituximab

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma

Eligibility Criteria

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

Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma No previous treatment Clinical stage II, III, or IV by the Ann Arbor Staging Criteria Age > 70 years ECOG performance status 0, 1, or 2 Adequate bone marrow, liver and kidney function Must give written informed consent prior to entering this trial Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years Central nervous system involvement with lymphoma Coexistent active malignancies treated within five years Active infection precluding the use of combination chemotherapy HIV infection Pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

Florida Cancer Specialists
Tennessee Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone

Arm Description

All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Full Information

NCT ID

NCT00193479

First Posted

September 12, 2005

Last Updated

February 21, 2022

Sponsor

SCRI Development Innovations, LLC

Collaborators

Genentech, Inc., Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00193479

Brief Title

Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

Official Title

A Phase II Trial of Brief Duration Combination Chemotherapy and Rituximab With Prophylactic Pegfilgrastim, Followed by Maintenance Rituximab, in Elderly/Poor Performance Status Patients With Large B-Cell Non-Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SCRI Development Innovations, LLC

Collaborators

Genentech, Inc., Amgen

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purposes of this trial are to decrease toxicity and improve treatment effectiveness elderly patients. With a short course of chemotherapy with cyclophosphamide, mitoxantrone, vincristine, and prednisone with concurrent administration of rituximab it is likely to be as effective as longer programs, and will certainly be better tolerated by this patient group. The addition of maintenance therapy may result in substantial prolongation of remission duration.

Detailed Description

Upon determination of eligibility, patients will receive: Cyclophosphamide + Mitoxantrone + Vincristine + Prednisone + Rituximab Patients that are not considered candidates for anthracycline therapy will not receive mitoxantrone. Patients with objective response (partial or complete response) or stable disease will receive Rituximab maintenance therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkins 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

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone

Arm Type

Experimental

Arm Description

All patients receive three courses of combination chemotherapy/rituximab followed by pegfilgrastim, administered at 21-day intervals. Treatment administered is as follows: cyclophosphamide 500mg/m2 IV day 1; mitoxantrone 10mg/m2 IV day 1; vincristine 1.0mg/m2 (maximum 2mg) IV day 1; prednisone 80mg PO days 1 - 5; rituximab 375mg/m2 IV day 1.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cytoxan

Intervention Description

Cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

Mitoxantrone

Other Intervention Name(s)

Novantrone

Intervention Description

Mitoxantrone

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Oncovin

Intervention Description

Vincristine

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Prednisone

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan

Intervention Description

Rituximab

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time Frame

18 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologically documented large B-cell, CD20-positive non-Hodgkin's lymphoma No previous treatment Clinical stage II, III, or IV by the Ann Arbor Staging Criteria Age > 70 years ECOG performance status 0, 1, or 2 Adequate bone marrow, liver and kidney function Must give written informed consent prior to entering this trial Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years Central nervous system involvement with lymphoma Coexistent active malignancies treated within five years Active infection precluding the use of combination chemotherapy HIV infection Pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D. Hainsworth, MD

Organizational Affiliation

SCRI Development Innovations, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Tennessee Oncology

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20223728

Citation

Hainsworth JD, Flinn IW, Spigel DR, Clark BL, Griner PL, Vazquez ER, Doss HH, Shipley D, Franco LA, Burris HA 3rd, Greco FA; Sarah Cannon Oncology Research Consortium. Brief-duration rituximab/chemotherapy followed by maintenance rituximab in patients with diffuse large B-cell lymphoma who are poor candidates for R-CHOP chemotherapy: a phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma Leuk. 2010 Feb;10(1):44-50. doi: 10.3816/CLML.2010.n.004.

Results Reference

result

Links:

URL

http://cigjournals.metapress.com/content/418721241w307702/

Description

Published article in Clinical Lymphoma, Myeloma and Leukemia

Non-Hodgkins Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial