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Dose ranging trial for pixantrone in the FND-R variant regimen in indolent non-Hodgkin's lymphoma



Dose ranging trial for pixantrone in the FND-R variant regimen in indolent non-Hodgkin's lymphoma

For Condition: Lymphoma, Small Lymphocytic,Lymphoma, Low-Grade,Lymphoma, Mixed-Cell, Follicular,Lymphoma, Small Cleaved-Cell, Follicular
Status: Recruiting
Sponsor(s): Novuspharma ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 30

Location and Contact Information:

Greater Baltimore Medical Center *Recruiting*
Baltimore,  Maryland,  21204
United States
Recruiting Lauren  Titus 443-849-3285

Arizona Clinical Research Center *Recruiting*
Tucson,  Arizona,  85712
United States
Recruiting Jarret  Schonbrun 520-290-2510

New Mexico Onc/Hem Consultants, Inc. *Recruiting*
Albuquerque,  New Mexico,  87109
United States
Recruiting Patti  Hopper 505-243-4039

MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Yolanda  Arredondo 713-745-2720


Additional Information:
Study ID Numbers:
  AZA I-06; 
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060684

Other Lymphoma, Mixed-Cell, Follicular Studies:
1. Dose ranging trial for pixantrone in the FND-R variant regimen in indolent non-Hodgkin's lymphoma

2. Comparative trial for pixantrone in combination with rituximab in indolent non-Hodgkin's lymphoma

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