Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00060671 |
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Recruitment Status :
Terminated
First Posted : May 12, 2003
Last Update Posted : January 19, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Follicular Lymphoma, Mixed-Cell, Follicular Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Low-Grade | Drug: rituximab Drug: Pixantrone (BBR 2778) | Phase 3 |
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:
- Patients treated with both pixantrone and rituximab, in combination
- 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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | January 2005 |
| Actual Primary Completion Date : | January 2006 |
| Actual Study Completion Date : | January 2006 |
- Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone [ Time Frame: For 5 years post treatment ]
- To compare BBR 2778 + rituximab versus rituximab for: [ Time Frame: For 5 years post treatment ]
- 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
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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 non-Hodgkin's lymphoma (NHL), including follicular lymphoma grade I and II
- Presenting with an episode of progressive disease, following 1-5 prior treatments (with either radiation, chemotherapy or rituximab).
Exclusion criteria:
- Patients that failed to respond to previous rituximab treatment, or relapsed within 6 months of the first rituximab infusion
- Patients known to have an allergic reaction to rituximab or murine derived proteins.
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): NCT00060671
Show 38 study locations
| Responsible Party: | CTI BioPharma |
| ClinicalTrials.gov Identifier: | NCT00060671 |
| Obsolete Identifiers: | NCT00062361 |
| Other Study ID Numbers: |
AZA III 02 |
| First Posted: | May 12, 2003 Key Record Dates |
| Last Update Posted: | January 19, 2015 |
| Last Verified: | May 2013 |
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Pixantrone BBR 2778 Non-Hodgkin's lymphoma chemotherapy DNA Intercalator Anthracycline Rituximab Rituxan |
Mabthera monoclonal antibody antibody NHL indolent low grade Novuspharma |
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Follicular Pixantrone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |