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

January 15, 2015 updated by: CTI BioPharma

A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Tucson, Arizona, United States, 85712
    - Arizona Clinical Research Center
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - New Mexico Onc/Hem Consultants, Inc.
- Texas
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria

Patients with relapsed or refractory indolent (low-grade) NHL
Who have received 1-3 prior treatments with chemotherapy

Exclusion criteria

Patients previously treated with fludarabine
Prior treatment with rituximab (Rituxan), unless there was a complete response (CR) or partial response (PR) to that treatment
Patients known to have an allergic reaction to rituximab, or to murine proteins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine MTD Time Frame: Per cycle	Per cycle

Secondary Outcome Measures

Outcome Measure	Time Frame
Establish safety profile Time Frame: per cycle	per cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Investigators

Study Director: Scott Stromatt, MD, CTI BioPharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Srokowski TP, Liebmann JE, Modiano MR, Cohen GI, Pro B, Romaguera JE, Kuepfer C, Singer JW, Fayad LE. Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 9, 2003

First Submitted That Met QC Criteria