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

Lymphoma, Small Lymphocytic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060684
• Other study ID #: AZA I-06
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2003
• Last updated: January 15, 2015
• Start date: December 2001
• Est. completion date: May 2007

Study information

• Verified date: September 2008
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00057772

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2007
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Low-Grade
• Lymphoma, Mixed-Cell, Follicular
• Lymphoma, Non-Hodgkin
• Lymphoma, Small Cleaved-Cell, Follicular
• Lymphoma, Small Lymphocytic

Intervention

Drug:
• Pixantrone (BBR 2778)

• fludarabine

• dexamethasone

• rituximab

Locations

Country	Name	City	State
United States	New Mexico Onc/Hem Consultants, Inc.	Albuquerque	New Mexico
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	MD Anderson Cancer Center	Houston	Texas
United States	Arizona Clinical Research Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine MTD		Per cycle	Yes
Secondary	Establish safety profile		per cycle	Yes