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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Follicular, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Low-Grade

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Trial Information

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)


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

AZA III 02

NCT ID:

NCT00060671

Start Date:

January 2005

Completion Date:

January 2006

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma, Mixed-Cell, Follicular
  • Lymphoma, Small Cleaved-Cell, Follicular
  • Lymphoma, Low-Grade
  • Pixantrone
  • BBR 2778
  • chemotherapy
  • DNA Intercalator
  • Anthracycline
  • Rituximab
  • Rituxan
  • Mabthera
  • monoclonal antibody
  • antibody
  • NHL
  • Non-Hodgkin's lymphoma
  • indolent
  • low grade
  • Novuspharma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Marshfield ClinicMarshfield, Wisconsin  54449
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Great Falls ClinicGreat Falls, Montana  59405
Ocala Oncology CenterOcala, Florida  34474
HemOnCare, P.C.Brooklyn, New York  11235
Arizona Clinical Research CenterTucson, Arizona  85712
Hope CenterTerre Haute, Indiana  47809
Kenmar Research InstituteLos Angeles, California  90057
Santee Hematology OncologySumter, South Carolina  29150
Oncology of WisconsinGlendale, Wisconsin  53212
St. Joseph OncologySt. Joseph, Missouri  64507
Hematology Oncology Associates of NJParamus, New Jersey  07652
The West ClinicMemphis, Tennessee  38120
New York UniversityNew York, New York  10016
Rocky Moutain Cancer CenterDenver, Colorado  80218
Pasco, Hernando Oncology Associates, P.A.New Port Richey, Florida  
Orange Park Cancer CenterOrange Park, Florida  32073
Illinois Masonic Cancer CenterChicago, Illinois  60657
University of Chicago Medical Center Hematology / OncologyChicago, Illinois  60637
Edward Cancer CenterNaperville, Illinois  60540
Commonwealth Hematology/OncologyDanville, Kentucky  40422
New England Hematology / Oncology AssociatesWellesley, Massachusetts  02481
St. Johns Mercy Medical CenterSt. Louis, Missouri  63141
Christian HospitalSt. Louis, Missouri  63136
Hematology - Oncology Centers of N. RockiesBillings, Montana  59101
East Orange VA Medical CenterEast Orange, New Jersey  07018
Summit Medical Group/Overlook Onc CenterSummit, New Jersey  07901
New Mexico Oncology / HematologyAlbuquerque, New Mexico  87109
Glens Falls Cancer CenterGlens Falls, New York  12801
North Shore - Long Island Jewish Health SystemNew Hyde Park, New York  11040
Upstate NY Cancer ResearchRochester, New York  14623
South Shore Hematology-Oncology AssociatesRockville Centre, New York  11570
Clinworks, IncCharlotte, North Carolina  
Private PracticeCanton, Ohio  44718
Blair Medical AssociatesAltoona, Pennsylvania  16601
Lancaster Cancer Center, LTDLancaster, Pennsylvania  17605
Central Utah Medical Clinic Hematology-OncologyProvo, Utah  84604
Rhinelander Regional Medical Group Onc.Rhinelander, Wisconsin  54501