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
18 Years
N/A
Both
Lymphoma, Low-Grade, Lymphoma, Small Lymphocytic, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular
Trial Information
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
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine MTD
Outcome Time Frame:
Per cycle
Safety Issue:
Yes
Principal Investigator
Scott Stromatt, MD
Investigator Role:
Study Director
Investigator Affiliation:
Cell Therapeutics
Authority:
United States: Food and Drug Administration
Study ID:
AZA I-06
NCT ID:
NCT00060684
Start Date:
December 2001
Completion Date:
May 2007
Related Keywords:
- Lymphoma, Low-Grade
- Lymphoma, Small Lymphocytic
- Lymphoma, Mixed-Cell, Follicular
- Lymphoma, Small Cleaved-Cell, Follicular
- Pixantrone
- BBR 2778
- chemotherapy
- DNA Intercalator
- mitoxantrone
- fludarabine
- dexamethasone
- Rituximab
- Rituxan
- Mabthera
- monoclonal antibody
- antibody
- NHL
- Non-Hodgkin's lymphoma
- indolent
- low grade
- Novuspharma
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Follicular
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
| Arizona Clinical Research Center | Tucson, Arizona 85712 |
| New Mexico Onc/Hem Consultants, Inc. | Albuquerque, New Mexico 87109 |
