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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkins Lymphoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI LYM 28

NCT ID:

NCT00193479

Start Date:

April 2003

Completion Date:

February 2010

Related Keywords:

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

Name

Location
Florida Cancer Specialists Fort Myers, Florida  33901
Tennessee Oncology Nashville, Tennessee  37203