Non-Hodgkin's LymphomaPhase 3NCT00577161
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
A Phase 3 study testing fludarabine and rituximab and fludarabine, rituximab, pixantrone in people with Non-Hodgkin's Lymphoma, run by CTI BioPharma at 8 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- fludarabine and rituximab and fludarabine, rituximab, pixantrone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2007to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cancer Care Center
Albany, New York, 12208
Hematology Oncology Consultants
Columbus, Ohio, 43235
Capitol Comprehensive Cancer Care
Jefferson City, Missouri, 65109
Heartland Hematology Oncology Associates
Kansas City, Missouri, 64118
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661
Utah Hematology Oncology, P.C.
Ogden, Utah, 84403
Ventura County Hematology Oncology Specialist
Oxnard, California, 93030
Interlakes Foundation, Inc.
Rochester, New York, 14623
About this study
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
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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- fludarabine and rituximab, fludarabine, rituximab, pixantrone
- Keywords
- pixantrone, NHL, rituximab, fludarabine
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludarabine and rituximabDrug
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2
fludarabine, rituximab, pixantroneDrug
days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | fludarabine and rituximab Receives: Drug: fludarabine and rituximab |
| Experimental | Experimental | fludarabine, rituximab, pixantrone Receives: Drug: fludarabine, rituximab, pixantrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: day 64-71
Secondary outcomes (1)
response rate, survival, safety
Measured: every 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: closed to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577161
- Sponsor's protocol ID
- PIX303
- Status last verified
- Oct 2020
- First submitted
- 17 Dec 2007
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00577161
- Acronym / sponsor ID
- PIX303
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- pixantrone, NHL, rituximab, fludarabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: closed to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2007 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Drug: fludarabine and rituximabfludarabine and rituximab |
| Experimental | Experimental | Drug: fludarabine, rituximab, pixantronefludarabine, rituximab, pixantrone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fludarabine and rituximabdays 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 | Drug | Comparator |
| fludarabine, rituximab, pixantronedays 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only | Drug | Experimental |
Primary outcome
progression-free survival
Time frame: day 64-71
1 secondary outcome
response rate, survival, safety
Time frame: every 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
Related trials for Non-Hodgkin's Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fludarabine and rituximab and fludarabine, rituximab, pixantrone in people with Non-Hodgkin's Lymphoma, run by CTI BioPharma at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: day 64-71). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.