Clinical trial NCT00193479: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkins Lymphoma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Amgen
First posted: 2005-09-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.