Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma
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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 |
- Determine MTD [ Time Frame: Per cycle ] [ Designated as safety issue: Yes ]
- 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) |
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 |
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| 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 | |
| Study Director: | Scott Stromatt, MD | Cell Therapeutics |
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 Cell Therapeutics:
|
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, Non-Hodgkin Lymphoma, Follicular Leukemia, B-Cell Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone |
Dexamethasone 21-phosphate Fludarabine Fludarabine monophosphate Pixantrone Rituximab BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013