NCT00058019

Brief Summary

This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2

Geographic Reach
1 country

2 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

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
Last Updated

May 23, 2014

Status Verified

October 1, 2011

Enrollment Period

7.5 years

First QC Date

April 7, 2003

Results QC Date

August 19, 2013

Last Update Submit

May 7, 2014

Conditions

Anaplastic Large Cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Objective Overall Response Rate

    The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.

    up to 3 years

  • Safety and Toxicity of Ixabepilone

    Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.

    up to 3 years

Secondary Outcomes (3)

  • Duration of Response

    up to 3 years

  • Overall Survival

    up to 3 years

  • Time to Progression

    up to 3 years

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.

Drug: ixabepilone

Interventions

ixabepiloneDRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra
Treatment (chemotherapy)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
  • Grade III follicular center
  • Diffuse large B-cell
  • Mantle cell
  • Primary mediastinal B-cell
  • Burkitt's
  • High-grade B-cell (Burkitt-like)
  • Anaplastic large cell of 1 of the following subtypes:
  • CD30-positive
  • T-cell
  • Null cell
  • Hodgkin's-like
  • Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts:
  • Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy
  • Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
  • +46 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, AnaplasticBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, FollicularLymphoma, Mantle-Cell

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-Cell

Results Point of Contact

Title
Dr. Sonali M. Smith
Organization
University of Chicago Medical Center
smsmith@medicine.bsd.uchicago.edu
773-834-2895

Study Officials

  • Sonali Smith

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

February 1, 2003

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 23, 2014

Results First Posted

February 27, 2014

Record last verified: 2011-10

Locations

US(2)