NCT00060684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 19, 2015

Status Verified

September 1, 2008

Enrollment Period

3.1 years

First QC Date

May 9, 2003

Last Update Submit

January 15, 2015

Conditions

Lymphoma, Low-GradeLymphoma, Small LymphocyticLymphoma, Mixed-Cell, FollicularLymphoma, Small Cleaved-Cell, Follicular

Keywords

PixantroneBBR 2778chemotherapyDNA IntercalatormitoxantronefludarabinedexamethasoneRituximabRituxanMabtheramonoclonal antibodyantibodyNHLNon-Hodgkin's lymphomaindolentlow gradeNovuspharma

Outcome Measures

Primary Outcomes (1)

  • Determine MTD

    Per cycle

Secondary Outcomes (1)

  • Establish safety profile

    per cycle

Interventions

Pixantrone (BBR 2778)DRUG
fludarabineDRUG
dexamethasoneDRUG
rituximabDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with relapsed or refractory indolent (low-grade) NHL
  • Who have received 1-3 prior treatments with chemotherapy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

New Mexico Onc/Hem Consultants, Inc.

Albuquerque, New Mexico, 87109, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related 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: 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.

    PMID: 21681734RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Follicular

Interventions

pixantronefludarabineDexamethasoneRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Scott Stromatt, MD

    CTI BioPharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2003

First Posted

May 12, 2003

Study Start

December 1, 2001

Primary Completion

January 1, 2005

Study Completion

May 1, 2007

Last Updated

January 19, 2015

Record last verified: 2008-09

Locations

US(4)