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

This study has been completed.
Sponsor:
Information provided by:
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00060684
First received: May 9, 2003
Last updated: September 18, 2008
Last verified: September 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • Determine MTD [ Time Frame: Per cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Establish safety profile [ Time Frame: per cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2001
Study Completion Date: May 2007
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 9, 2003
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration

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:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, B-Cell
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fludarabine
Fludarabine phosphate
Pixantrone
Rituximab
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2014