Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma

Phase 1

Completed

• Conditions: Lymphoma, Low-Grade; Lymphoma, Small Lymphocytic; Lymphoma, Small Cleaved-Cell, Follicular; Lymphoma, Mixed-Cell, Follicular

• Registration Number: NCT00060684
• Lead Sponsor: CTI BioPharma

Brief Summary

The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.

Detailed Description

The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.

This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2003-05-09
• Study First Submitted QC: 2003-05-09
• Study First Posted: 2003-05-12
• Primary Completion: 2005-01
• Study Completion: 2007-05
• Status Verified: 2008-09
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine MTD	Per cycle

Secondary Outcome Measures

Name	Time	Method
Establish safety profile	per cycle

Trial Locations

Locations (4)

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

New Mexico Onc/Hem Consultants, Inc.; 🇺🇸 Albuquerque, New Mexico, United States