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

S

SCRI Development Innovations

Status and phase

Completed
Phase 2

Conditions

Non-Hodgkins Lymphoma

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00193479
SCRI LYM 28

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

51 participants in 1 patient group

Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone
Experimental group
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.
Treatment:
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Vincristine
Drug: Mitoxantrone
Drug: Prednisone

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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