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

Non-Hodgkins Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193479
• Other study ID #: SCRI LYM 28
• Status: Completed
• Phase: Phase 2
• Start date: April 2003
• Est. completion date: February 2010

Study information

• Verified date: February 2022
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide
• Mitoxantrone
Mitoxantrone
• Vincristine
Vincristine
• Prednisone
Prednisone
• Rituximab
Rituximab

Locations

Country	Name	City	State
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Amgen, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 Months

External Links

•   Published article in Clinical Lymphoma, Myeloma and Leukemia