Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkin's Lymphoma

Sponsor

CTI BioPharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00060671

Collaborator

(none)

800

Enrollment

Locations

Duration (Months)

21.1

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether combining pixantrone (BBR 2778, INN name pending) with the monoclonal antibody rituximab, leads to an increase in the period of patients' remission, compared to rituximab alone.

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

Detailed Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2005

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Compare the time to tumor progression (TTP) of the combination of BBR 2778 (pixantrone) + rituximab with that of rituximab alone [For 5 years post treatment]

Secondary Outcome Measures

To compare BBR 2778 + rituximab versus rituximab for: [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Clinical Research Center	Tucson	Arizona	United States	85712
2	Sutter Health Western Division Cancer Research Group	Greenbrae	California	United States	94904
3	Kenmar Research Institute	Los Angeles	California	United States	90057
4	Rocky Moutain Cancer Center	Denver	Colorado	United States	80218
5	Pasco, Hernando Oncology Associates, P.A.	New Port Richey	Florida	United States
6	Ocala Oncology Center	Ocala	Florida	United States	34474
7	Orange Park Cancer Center	Orange Park	Florida	United States	32073
8	University of Chicago Medical Center Hematology / Oncology	Chicago	Illinois	United States	60637
9	Illinois Masonic Cancer Center	Chicago	Illinois	United States	60657
10	Edward Cancer Center	Naperville	Illinois	United States	60540
11	Hope Center	Terre Haute	Indiana	United States	47802
12	Commonwealth Hematology/Oncology	Danville	Kentucky	United States	40422
13	New England Hematology / Oncology Associates	Wellesley	Massachusetts	United States	02481
14	St. Joseph Oncology	St Joseph	Missouri	United States	64507
15	Christian Hospital	St Louis	Missouri	United States	63136
16	St. Johns Mercy Medical Center	St. Louis	Missouri	United States	63141
17	Hematology - Oncology Centers of N. Rockies	Billings	Montana	United States	59101
18	Great Falls Clinic	Great Falls	Montana	United States	59405
19	East Orange VA Medical Center	East Orange	New Jersey	United States	07018
20	Hematology Oncology Associates of NJ	Paramus	New Jersey	United States	07652
21	Summit Medical Group/Overlook Onc Center	Summit	New Jersey	United States	07901
22	New Mexico Oncology / Hematology	Albuquerque	New Mexico	United States	87109
23	HemOnCare, P.C.	Brooklyn	New York	United States	11235
24	Glens Falls Cancer Center	Glens Falls	New York	United States	12801
25	North Shore - Long Island Jewish Health System	New Hyde Park	New York	United States	11040
26	New York University	New York	New York	United States	10016
27	Upstate NY Cancer Research	Rochester	New York	United States	14623
28	South Shore Hematology-Oncology Associates	Rockville Centre	New York	United States	11570
29	Clinworks, Inc	Charlotte	North Carolina	United States
30	Private Practice	Canton	Ohio	United States	44718
31	Blair Medical Associates	Altoona	Pennsylvania	United States	16601
32	Lancaster Cancer Center, LTD	Lancaster	Pennsylvania	United States	17605
33	Santee Hematology Oncology	Sumter	South Carolina	United States	29150
34	The West Clinic	Memphis	Tennessee	United States	38120
35	Central Utah Medical Clinic Hematology-Oncology	Provo	Utah	United States	84604
36	Oncology of Wisconsin	Glendale	Wisconsin	United States	53212
37	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
38	Rhinelander Regional Medical Group Onc.	Rhinelander	Wisconsin	United States	54501