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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00577161
• Other study ID #: PIX303
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: July 2012

Study information

• Verified date: October 2020
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL)

2. Any stage (Ann Arbor staging, Appendix 15.7), with or without B symptoms

3. CD 20+ lymphoma (confirmed by immunochemistry)

4. Measurable disease.

5. Atleast 1 prior therapy.

6. Age = 18 years

7. Life expectancy of at least 3 months

8. ECOG performance status (PS) of 0 or 1

9. Adequate cardiac function defined as LVEF = 50% by MUGA scan

10. Adequate renal function

11. Adequate hepatic function

12. Adequate bone marrow function

13. Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).

Exclusion Criteria

1. Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2

2. Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start

3. Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment.

4. Radioimmunotherapy (RIT) within 3 months of treatment start

5. Known hypersensitivity to the excipients or the study drugs that the patient will receive

6. Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab

7. 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)

8. HIV-related lymphoma

9. Active CNS involvement

10. Clinically significant cardiovascular abnormalities

11. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.

12. Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.

13. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .

14. 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

15. Pregnant or lactating women

16. 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Cancer Care Center	Albany	New York
United States	Hematology Oncology Consultants	Columbus	Ohio
United States	Capitol Comprehensive Cancer Care	Jefferson City	Missouri
United States	Heartland Hematology Oncology Associates	Kansas City	Missouri
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Utah Hematology Oncology, P.C.	Ogden	Utah
United States	Ventura County Hematology Oncology Specialist	Oxnard	California
United States	Interlakes Foundation, Inc.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		day 64-71
Secondary	response rate, survival, safety		every 21 days