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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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ClinicalTrials.gov Identifier: NCT00060684
Recruitment Status : Completed
First Posted : May 12, 2003
Last Update Posted : January 19, 2015
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.

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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

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

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

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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
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Study Director: Scott Stromatt, MD CTI BioPharma
Publications of Results:
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Responsible Party: Gabriella Camboni, M.D., Cell Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00060684    
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:
BBR 2778
DNA Intercalator
monoclonal antibody
Non-Hodgkin's lymphoma
low grade
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists