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Pixantrone

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Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Pixantrone (BBR 2778)

fludarabine

dexamethasone

rituximab

Scott Stromatt, MD

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.

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.

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

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

CTI BioPharma

Gabriella Camboni, M.D.

The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.

This trial is being conducted in patients with indolent (or low-grade) non-Hodgkin's lymphoma, who have either relapsed or been refractory to previous treatment.

Pixantrone belongs to the DNA intercalator family of chemotherapy agents, which includes anthracyclines. DNA intercalators are commonly used to treat patients with indolent NHL, often in combination with the monoclonal antibody rituximab. This study represents the first large-scale, comparative trial in indolent NHL, designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator, is significantly higher than seen in patients treated with rituximab alone.

This trial is randomized and controlled, which means that participating patients will be randomly assigned to one of two treatment groups:

1. Patients treated with both pixantrone and rituximab, in combination
2. Patients treated with only rituximab

This trial is expected to recruit around 800 patients in the US, Europe and Israel, with 400 patients recruited to each group.

Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment.

Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma

An Open-Label, Randomized, Phase III Comparative Trial of BBR 2778 + Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)

* objective overall response rate (ORR; CR + PR)
* objective complete response rate (CRR)
* rate of molecular remission
* time to response
* time to complete response
* duration of response
* Time to Tumor Progression requiring treatment
* Quality-Adjusted Time To Progression (QATTP)
* overall survival
* disease-specific survival
* safety/tolerability

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma	NCT00060684	Lymphoma, Low-G... Lymphoma, Small... Lymphoma, Mixed... Lymphoma, Small...	Pixantrone (BBR... fludarabine dexamethasone rituximab	18 Years -	CTI BioPharma
Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma	NCT00060671	Lymphoma, Folli... Lymphoma, Mixed... Lymphoma, Small... Lymphoma, Low-G...	rituximab Pixantrone (BBR...	18 Years -	CTI BioPharma

Spots Global Cancer Trial Database for pixantrone (bbr 2778)