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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pixantrone (BBR 2778)

fludarabine

dexamethasone

rituximab

About this trial

This is an interventional treatment trial for Lymphoma, Low-Grade focused on measuring Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, mitoxantrone, fludarabine, dexamethasone, Rituximab, Rituxan, Mabthera, monoclonal antibody, antibody, NHL, Non-Hodgkin's lymphoma, indolent, low grade, Novuspharma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arizona Clinical Research Center
Greater Baltimore Medical Center
New Mexico Onc/Hem Consultants, Inc.
MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Determine MTD

Secondary Outcome Measures

Establish safety profile

Full Information

NCT ID

NCT00060684

First Posted

May 9, 2003

Last Updated

January 15, 2015

Sponsor

CTI BioPharma

1. Study Identification

Unique Protocol Identification Number

NCT00060684

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

December 2001 (undefined)

Primary Completion Date

January 2005 (Actual)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

CTI BioPharma

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pixantrone (BBR 2778)

Intervention Type

Drug

Intervention Name(s)

fludarabine

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Type

Drug

Intervention Name(s)

rituximab

Primary Outcome Measure Information:

Title

Determine MTD

Time Frame

Per cycle

Secondary Outcome Measure Information:

Title

Establish safety profile

Time Frame

per cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Stromatt, MD

Organizational Affiliation

CTI BioPharma

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Clinical Research Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Greater Baltimore Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

New Mexico Onc/Hem Consultants, Inc.

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21681734

Citation

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: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16.

Results Reference

result

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

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