ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00060684
Recruitment Status : Completed
First Posted : May 12, 2003
Last Update Posted : January 19, 2015
Sponsor:
Information provided by:
CTI BioPharma

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Low-Grade Lymphoma, Small Lymphocytic Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Drug: Pixantrone (BBR 2778) Drug: fludarabine Drug: dexamethasone Drug: rituximab Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : May 2007





Primary Outcome Measures :
  1. Determine MTD [ Time Frame: Per cycle ]

Secondary Outcome Measures :
  1. Establish safety profile [ Time Frame: per cycle ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060684


Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, New Mexico
New Mexico Onc/Hem Consultants, Inc.
Albuquerque, New Mexico, United States, 87109
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Director: Scott Stromatt, MD CTI BioPharma

Publications of Results:
Responsible Party: Gabriella Camboni, M.D., Cell Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00060684     History of Changes
Obsolete Identifiers: NCT00057772
Other Study ID Numbers: AZA I-06
First Posted: May 12, 2003    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: September 2008

Keywords provided by CTI BioPharma:
Pixantrone
BBR 2778
chemotherapy
DNA Intercalator
mitoxantrone
fludarabine
dexamethasone
Rituximab
Rituxan
Mabthera
monoclonal antibody
antibody
NHL
Non-Hodgkin's lymphoma
indolent
low grade
Novuspharma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Dexamethasone acetate
Dexamethasone
Fludarabine
Fludarabine phosphate
Pixantrone
Rituximab
BB 1101
Antibodies
Vidarabine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones