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

Sponsor

CTI BioPharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00060684

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Low-Grade Lymphoma, Small Lymphocytic Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular	Drug: Pixantrone (BBR 2778) Drug: fludarabine Drug: dexamethasone Drug: rituximab	Phase 1

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Determine MTD [Per cycle]

Secondary Outcome Measures

Establish safety profile [per cycle]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Clinical Research Center	Tucson	Arizona	United States	85712
2	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
3	New Mexico Onc/Hem Consultants, Inc.	Albuquerque	New Mexico	United States	87109
4	MD Anderson Cancer Center	Houston	Texas	United States	77030