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

Tracking Information

First Received Date ^ICMJE

May 9, 2003

Last Updated Date

September 18, 2008

Start Date ^ICMJE

December 2001

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine MTD [ Time Frame: Per cycle ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00060684 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Establish safety profile [ Time Frame: per cycle ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lymphoma, Low-Grade
Lymphoma, Small Lymphocytic
Lymphoma, Mixed-Cell, Follicular
Lymphoma, Small Cleaved-Cell, Follicular

Intervention ^ICMJE

Drug: Pixantrone (BBR 2778)
Drug: fludarabine
Drug: dexamethasone
Drug: rituximab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

January 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00060684

Responsible Party

Gabriella Camboni, M.D., Cell Therapeutics, Inc.

Study ID Numbers ^ICMJE

AZA I-06

Study Sponsor ^ICMJE

Cell Therapeutics

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Scott Stromatt, MD

Cell Therapeutics

Information Provided By

Cell Therapeutics

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP