NCT00193479|CompletedPhase 2Results

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

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

SCRI Development Innovations, LLC ClinicalTrials.gov

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1 other identifier

SCRI LYM 28

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredSep 2005

StartedApr 2003

CompletionFeb 2010

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Apr 2003

Longer than P75 for phase_2

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

April 1, 2003

Completed

2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

February 21, 2014

Completed

Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Results QC Date

January 8, 2014

Last Update Submit

February 21, 2022

Conditions

Non-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Cyclophosphamide/Vincristine/Rituximab +/- Mitoxantrone

EXPERIMENTAL

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.

Drug: CyclophosphamideDrug: MitoxantroneDrug: VincristineDrug: PrednisoneDrug: Rituximab