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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pixantrone (BBR 2778)

Intervention Type DRUG

fludarabine

Intervention Type DRUG

dexamethasone

Intervention Type DRUG

rituximab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No