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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lymphoma, Low-Grade, Lymphoma, Small Lymphocytic, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular

Intervention / Treatment
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* Drug: Pixantrone (BBR 2778)
* Drug: fludarabine
* Drug: dexamethasone
* Drug: rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pixantrone (BBR 2778)|nan|
|Drug: fludarabine|nan|
|Drug: dexamethasone|nan|
|Drug: rituximab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine MTD |  | Per cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish safety profile |  | per cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, mitoxantrone, fludarabine, dexamethasone, Rituximab, Rituxan, Mabthera, monoclonal antibody, antibody, Non-Hodgkin's lymphoma, indolent, low grade, Novuspharma