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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Low-Grade, Lymphoma, Small Lymphocytic, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular

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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 CenterHouston, Texas  77030-4096
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Arizona Clinical Research CenterTucson, Arizona  85712
New Mexico Onc/Hem Consultants, Inc.Albuquerque, New Mexico  87109