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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00060684

Enrollment

Registered

2003-05-12

Start date

2001-12-31

Completion date

2007-05-31

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, mitoxantrone, fludarabine, dexamethasone, Rituximab, Rituxan, Mabthera, monoclonal antibody, antibody, NHL, Non-Hodgkin's lymphoma, indolent, low grade, Novuspharma

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.

Interventions

DRUGPixantrone (BBR 2778)

DRUGfludarabine

DRUGdexamethasone

DRUGrituximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Determine MTD	Per cycle

Secondary

Measure	Time frame
Establish safety profile	per cycle

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026