Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL

Sponsor

CTI BioPharma (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00577161

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7).

This phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: fludarabine and rituximab Drug: fludarabine, rituximab, pixantrone	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Actual Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Comparator fludarabine and rituximab	Drug: fludarabine and rituximab days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
Experimental: Experimental fludarabine, rituximab, pixantrone	Drug: fludarabine, rituximab, pixantrone days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only

Arm

Intervention/Treatment

Active Comparator: Comparator

fludarabine and rituximab

Drug: fludarabine and rituximab

days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2

Experimental: Experimental

fludarabine, rituximab, pixantrone

Drug: fludarabine, rituximab, pixantrone

days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only

Outcome Measures

Primary Outcome Measures

progression-free survival [day 64-71]

Secondary Outcome Measures

response rate, survival, safety [every 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL)
Any stage (Ann Arbor staging, Appendix 15.7), with or without B symptoms
CD 20+ lymphoma (confirmed by immunochemistry)
Measurable disease.
Atleast 1 prior therapy.
Age ≥ 18 years
Life expectancy of at least 3 months
ECOG performance status (PS) of 0 or 1
Adequate cardiac function defined as LVEF ≥ 50% by MUGA scan
Adequate renal function
Adequate hepatic function
Adequate bone marrow function
Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).

Exclusion Criteria

Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2
Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start
Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment.
Radioimmunotherapy (RIT) within 3 months of treatment start
Known hypersensitivity to the excipients or the study drugs that the patient will receive
Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab
Major thoracic and/or abdominal surgery in the preceding 4 weeks, from which the patient has not fully recovered (patients who have had minor surgery and one week's recovery period may be enrolled)
HIV-related lymphoma
Active CNS involvement
Clinically significant cardiovascular abnormalities
Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.
Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.
Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .
History of another malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years
Pregnant or lactating women
Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest Alabama Cancer Center	Muscle Shoals	Alabama	United States	35661
2	Ventura County Hematology Oncology Specialist	Oxnard	California	United States	93030
3	Capitol Comprehensive Cancer Care	Jefferson City	Missouri	United States	65109
4	Heartland Hematology Oncology Associates	Kansas City	Missouri	United States	64118
5	Cancer Care Center	Albany	New York	United States	12208
6	Interlakes Foundation, Inc.	Rochester	New York	United States	14623
7	Hematology Oncology Consultants	Columbus	Ohio	United States	43235
8	Utah Hematology Oncology, P.C.	Ogden	Utah	United States	84403