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

• ClinicalTrials.gov Identifier: NCT00577161
• Recruitment Status: Withdrawn
• First Posted: December 19, 2007
• Last Update Posted: October 5, 2020
• Sponsor: CTI BioPharma
• Information provided by (Responsible Party): CTI BioPharma

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 (Clinical Trial)
• 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: September 2007
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: July 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

Outcome Measures

Primary Outcome Measures :

1. progression-free survival [ Time Frame: day 64-71 ]

Secondary Outcome Measures :

1. response rate, survival, safety [ Time Frame: every 21 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, United States, 35661

United States, California

Ventura County Hematology Oncology Specialist

Oxnard, California, United States, 93030

United States, Missouri

Capitol Comprehensive Cancer Care

Jefferson City, Missouri, United States, 65109

Heartland Hematology Oncology Associates

Kansas City, Missouri, United States, 64118

United States, New York

Cancer Care Center

Albany, New York, United States, 12208

Interlakes Foundation, Inc.

Rochester, New York, United States, 14623

United States, Ohio

Hematology Oncology Consultants

Columbus, Ohio, United States, 43235

United States, Utah

Utah Hematology Oncology, P.C.

Ogden, Utah, United States, 84403

Sponsors and Collaborators

CTI BioPharma

More Information

• Responsible Party: CTI BioPharma
• ClinicalTrials.gov Identifier: NCT00577161
• Other Study ID Numbers: PIX303
• First Posted: December 19, 2007
• Last Update Posted: October 5, 2020
• Last Verified: October 2020

Keywords provided by CTI BioPharma:

pixantrone; NHL; rituximab; fludarabine

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Pixantrone; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Vidarabine; Rituximab; Fludarabine; Fludarabine phosphate; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Antiviral Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors