Lymphoma, Low-GradePhase 1NCT00060684
Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkin's Lymphoma
A Phase 1 study testing Pixantrone (BBR 2778), fludarabine and dexamethasone in people with Lymphoma, Low-Grade and Lymphoma, Small Lymphocytic, run by CTI BioPharma at 4 sites in United States.
Trial summary
The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Low-Grade, Lymphoma, Small Lymphocytic, Lymphoma, Mixed-Cell, Follicular
- What is being tested?
- Pixantrone (BBR 2778), fludarabine and dexamethasone
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2001to May 2007
- Phase
- Phase 1
- 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
- Patients with relapsed or refractory indolent (low-grade) NHL
- Who have received 1-3 prior treatments with chemotherapy
Who cannot join
- Patients previously treated with fludarabine
- Prior treatment with rituximab (Rituxan), unless there was a complete response (CR) or partial response (PR) to that treatment
- Patients known to have an allergic reaction to rituximab, or to murine proteins.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Mexico Onc/Hem Consultants, Inc.
Albuquerque, New Mexico, 87109
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
MD Anderson Cancer Center
Houston, Texas, 77030
Arizona Clinical Research Center
Tucson, Arizona, 85712
About this study
Official title: A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.
Read the detailed description
The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.
This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.
- Conditions
- Lymphoma, Low-Grade, Lymphoma, Small Lymphocytic, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular
- Being tested
- Pixantrone (BBR 2778), fludarabine, dexamethasone, rituximab
- Keywords
- Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, mitoxantrone, fludarabine, dexamethasone, Rituximab, Rituxan, Mabthera, monoclonal antibody, antibody, NHL, Non-Hodgkin's lymphoma, indolent, low grade, Novuspharma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pixantrone (BBR 2778)Drug
fludarabineDrug
dexamethasoneDrug
rituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MTD
Measured: Per cycle
Secondary outcomes (1)
Establish safety profile
Measured: per cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2003 (estimated)
- Study startDec 2001
- Primary completionJan 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Low-GradeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Stromatt, MD, Study director, CTI BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060684
- Sponsor's protocol ID
- AZA I-06
- Status last verified
- Sep 2008
- First submitted
- 9 May 2003
- Last updated
- 19 Jan 2015
- Results posted
- No
Publications
Srokowski TP, Liebmann JE, Modiano MR, Cohen GI, Pro B, Romaguera JE, Kuepfer C, Singer JW, Fayad LE. Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16.
PubMed 21681734
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of BBR 2778 in Combination With Fludarabine, Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00060684
- Acronym / sponsor ID
- AZA I-06
- Conditions
- Lymphoma, Low-Grade, Lymphoma, Small Lymphocytic, Lymphoma, Mixed-Cell, Follicular, Lymphoma, Small Cleaved-Cell, Follicular
- Keywords
- Pixantrone, BBR 2778, chemotherapy, DNA Intercalator, mitoxantrone, fludarabine, dexamethasone, Rituximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 May 2003 (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.
The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.
Detailed description
The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkin's lymphoma (NHL) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. In this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are DNA intercalators). The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs.
This trial is expected to recruit up to 30 patients in the USA. Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. After that, patients will receive physician check-ups every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with relapsed or refractory indolent (low-grade) NHL
- Who have received 1-3 prior treatments with chemotherapy
Key exclusion criteria (3 listed)
- Patients previously treated with fludarabine
- Prior treatment with rituximab (Rituxan), unless there was a complete response (CR) or partial response (PR) to that treatment
- Patients known to have an allergic reaction to rituximab, or to murine proteins.
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 |
|---|---|---|
| Pixantrone (BBR 2778) | Drug | – |
| fludarabine | Drug | – |
| dexamethasone | Drug | – |
| rituximab | Drug | – |
Primary outcome
Determine MTD
Time frame: Per cycle
1 secondary outcome
Establish safety profile
Time frame: per cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Results publication: PubMed 21681734Srokowski TP, Liebmann JE, Modiano MR, Cohen GI, Pro B, Romaguera JE, Kuepfer C, Singer JW, Fayad LE. Pixantrone dimaleate in combination with fludarabine, dexamethasone, and rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: phase 1 study with a dose-expansion cohort. Cancer. 2011 Nov 15;117(22):5067-73. doi: 10.1002/cncr.26121. Epub 2011 Jun 16.
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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.
Scott Stromatt, MD study director
CTI BioPharma
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pixantrone (BBR 2778), fludarabine and dexamethasone in people with Lymphoma, Low-Grade and Lymphoma, Small Lymphocytic, run by CTI BioPharma at 4 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine MTD (time frame: Per cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060684, which also lists 1 linked publication.
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 19 Jan 2015.